Noise ExposureLEON-TNCT05611619
Low Particle Emission and Low Noise Tyres
A study testing Tyre noise - continuous flow, Tyre noise - discrete events and High noise level in people with Noise Exposure and Sleep Disturbance, run by Göteborg University at 1 site in Sweden.
Trial summary
This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, the investigators will play synthesised automotive tyre sounds, investigating how acoustical characteristics of tyre noise impact on sleep macrostructure, cardiometabolic… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure, Sleep Disturbance, Sleep Hygiene
- What is being tested?
- Tyre noise - continuous flow, Tyre noise - discrete events and High noise level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jan 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. live in or around the city of Gothenburg area (Sweden)
Who cannot join
- aged <18 or >30 years;
- habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00);
- BMI>25 kg/m2;
- regular sleep medication use (prescribed or "over-the-counter");
- poor hearing acuity (measured during screening via pure tone audiometry);
- diagnosed with sleep disorders;
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- indications of sleep apnea on the STOP-BANG questionnaire;
- shift work;
- smoking, vaping, snus, or other nicotine use.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg
Gothenburg, Västra Götaland County, 42650
About this study
This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, the investigators will play synthesised automotive tyre sounds, investigating how acoustical characteristics of tyre noise impact on sleep macrostructure, cardiometabolic profile and cognitive performance (continuous traffic flow or a few individual, but higher level, traffic pass-bys). The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analysed to identify metabolic changes in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which chronic noise exposure at night can lead to the development of diseases in the long term, especially cardiometabolic disorders.
Read the detailed description
The experimental sleep study has the overarching goal of deepening our understanding of sleep disruption by automotive tyre noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following independent aims:
Aim 1: Determine the biological and neurobehavioural consequences of sleep disruption by tyre noise. The investigators will measure the sleep of healthy volunteers, and each morning the investigators will obtain blood samples for metabolomics analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics and cognitive function between quiet nights and nights with road traffic noise.
Aim 2: Identify acoustical characteristics of tyre noise that are especially disturbing physiologically. The investigators will use different combinations of types of tyre noise in different noise exposure nights to determine differential effects on sleep and cardiovascular response.
This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine (Arbets- och miljömedicin [AMM]). The SEL is a high fidelity research laboratory equipped to simulate a typical apartment, including three individually light-, sound- and vibration-isolated private bedrooms. Ceiling mounted speakers in each room allow the investigators to create a realistic acoustic environment by transmitting sound exposures from the control room to each bedroom individually. The investigators have shown previously that results from this lab with high ecological validity are comparable with results from the field.
There will be two study arms, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. Participants (study 1 N=15; study 2 N=30; total N=45 across both arms) will each spend six consecutive nights in the SEL, with a sleep opportunity between 23:00-07:00. Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist actigraphy monitors worn continuously throughout the study. Three subjects will take part concurrently, in separate bedrooms. The first night is a habituation period to the study protocol and for familiarisation with the test procedures. Study nights 2-6 are the experimental nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to each of the following:
One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance;
Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that the investigators can examine each combination of two specific noise characteristics.
Each night the investigators will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 4 ml blood sample, complete cognitive testing and answer questionnaires and will depart the SEL to follow their normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at all times. Because extreme and/or variable dietary behaviour can affect the metabolome/lipoprotein profile, participants will be given guidance that they should eat a similar evening meal on each day of the laboratory study, confirmed with a food diary, The actual meal itself can be different for different study participants, because the study has a within-subjects design.
Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto the sleep recorder, and will be downloaded and checked every study morning to ensure data quality. In addition to traditional sleep analysis performed by the research group at the University of Gothenburg, raw PSG data will be used to calculate the Odds Ratio Project, a novel metric of sleep depth and stability.
Each study morning subjects will provide a 4 ml blood sample for plasma metabolomics analysis. To ensure reliable data, blood samples will be taken at the same time every day to mitigate circadian effects, before eating or drinking anything except water, and each sample will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers. Subjects will eat the same food each study evening to mitigate within-subject dietary effects on the blood metabolome.
Each morning, subjects will complete a computerised cognitive test battery taking approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance). Cognition data will be analysed to determine key measures of cognitive speed and accuracy, adjusting for practice effects and the difficulty of the stimulus set.
Subjects will complete a battery of one-time validated questionnaires to measure their general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a questionnaire each study evening and morning, involving questions on sleepiness (Karolinska Sleepiness Scale), sleep disturbance by noise, positive and negative affect (PANAS), and validated sleep and disturbance questions.
Participants will wear a wrist actigraphy monitor continuously throughout the study period, and also for the week before the study, to confirm habitual sleep-wake times and to measure physical activity levels.
- Being tested
- Tyre noise - continuous flow, Tyre noise - discrete events, High noise level, Moderate noise level, Low noise level
- Keywords
- Neurobehavioural Performance, Polysomnography, Metabolomics
- Medical subject headings
- Parasomnias, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyre noise - continuous flowRadiation
Tyre noise from continuous traffic, throughout the night
Tyre noise - discrete eventsRadiation
Tyre noise from few, discrete traffic events, occurring throughout the night
High noise levelRadiation
Tyre noise corresponding up to 65 dB LAEq,24h
Moderate noise levelRadiation
Tyre noise corresponding up to 60 dB LAEq,24h
Low noise levelRadiation
Tyre noise corresponding up to 55 dB LAEq,24h
Air-filled tyresRadiation
Tyre noise from traditional, air-filled tyres
Composite tyresRadiation
Tyre noise from newly designed, airless composite tyres
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Single study night with no noise exposure, to determine normal baseline sleep |
| Study 1: High level continuous flow tyre noise (A1) | Experimental | Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by high level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. Receives: Radiation: Tyre noise - continuous flow; Radiation: High noise level |
| Study 1: Medium level continuous flow tyre noise (B1) | Experimental | Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. Receives: Radiation: Tyre noise - continuous flow; Radiation: Moderate noise level |
| Study 1: High level, discrete traffic tyre noise (A2) | Experimental | Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by high level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. Receives: Radiation: Tyre noise - discrete events; Radiation: High noise level |
| Study 1: Medium level, discrete traffic tyre noise (B2) | Experimental | Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by moderate level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. Receives: Radiation: Tyre noise - discrete events; Radiation: Moderate noise level |
| Study 2: Medium level composite wheel tyre noise (A1) | Experimental | Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of composite wheel types. Receives: Radiation: Moderate noise level; Radiation: Composite tyres |
| Study 2: Low level composite wheel tyre noise (B1) | Experimental | Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of composite wheel types. Receives: Radiation: Low noise level; Radiation: Composite tyres |
| Study 2: Medium level air-filled tyre noise (A2) | Experimental | Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of traditional air-filled wheel types. Receives: Radiation: Moderate noise level; Radiation: Air-filled tyres |
| Study 2: Low level air-filled tyre noise (B2) | Experimental | Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of traditional air-filled wheel types. Receives: Radiation: Low noise level; Radiation: Air-filled tyres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline total sleep time during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Baseline total sleep time during the A1 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Baseline total sleep time during the A2 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Baseline total sleep time during the B1 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Baseline total sleep time during the B2 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total sleep time during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total sleep time during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total sleep time during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total sleep time during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of baseline N1 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of baseline N2 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of baseline N3 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of baseline rapid eye movement (REM) sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Baseline wakefulness after sleep onset (WASO) during the Control night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A1
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A2
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B1
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B2
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Baseline number of awakenings during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Number of awakenings during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Number of awakenings during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Number of awakenings during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Number of awakenings during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Measured: One night
Baseline sleep onset latency (SOL) during the Control night
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A1
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A2
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B1
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B2
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Baseline sleep efficiency during the Control night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep efficiency during exposure to nocturnal tyre noise combination A1
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep efficiency during exposure to nocturnal tyre noise combination A2
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep efficiency during exposure to nocturnal tyre noise combination B1
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Sleep efficiency during exposure to nocturnal tyre noise combination B2
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Measured: One night
Baseline sleep depth assessed using the odds ratio product (ORP) during the Control night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Measured: One night
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A1
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Measured: One night
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A2
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Measured: One night
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B1
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Measured: One night
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B2
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Measured: One night
Spontaneous maximal change of odds ratio product (ORP) during the Control night
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over 120 sham noise events during the night.
Measured: One night
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A1
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Measured: One night
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A2
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Measured: One night
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B1
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Measured: One night
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B2
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Measured: One night
Morning neurobehavioural speed in the morning immediately after the Control night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Morning neurobehavioural speed in the morning immediately after the A1 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Morning neurobehavioural speed in the morning immediately after the A2 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Morning neurobehavioural speed in the morning immediately after the B1 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Morning neurobehavioural speed in the morning immediately after the B2 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Morning neurobehavioural accuracy in the morning after the control night
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A1
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A2
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B1
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B2
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Baseline evening neurobehavioural speed following the Control night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A1
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A2
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B1
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B2
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Measured: One night
Baseline evening neurobehavioural accuracy following the Control night
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance
Measured: One night
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A1
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A2
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B1
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B2
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Measured: One night
Event-related Cardiovascular activation in response to noise during Control night
Change in heart rate (ECG)
Measured: One night
Event-related Cardiovascular activation in response to noise during A1
Change in heart rate (ECG)
Measured: One night
Event-related Cardiovascular activation in response to noise during A2
Change in heart rate (ECG)
Measured: One night
Event-related Cardiovascular activation in response to noise during B1
Change in heart rate (ECG)
Measured: One night
Event-related Cardiovascular activation in response to noise during B2
Change in heart rate (ECG)
Measured: One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the control night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the control night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Measured: One night
Taurine concentration (mmol/L) immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Serotonin concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Tryptophan concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Isoleucine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Leucine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Valine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Lauroylcarnitine (C12:0) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Phenylalanine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 32:1 concentration (mmol/L)In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Basline Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Baseline Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Measured: One night
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start30 Jan 2023
- Primary completion16 Jun 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There will be two separate study periods, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. The order of the noise exposure conditions will be be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to one night of each of the following: One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance; Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that we can examine each combination of two specific noise characteristics.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of Manitoba, Swedish National Road and Transport Research Institute
- Responsible party
- Sponsor
- Investigators
- Michael G Smith, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611619
- Sponsor's protocol ID
- 254066204
- Acronym
- LEON-T
- Status last verified
- Jan 2024
- First submitted
- 23 Sep 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Particle Emission and Low Noise Tyres
- ClinicalTrials.gov ID
- NCT05611619
- Acronym / sponsor ID
- LEON-T / 254066204
- Keywords
- Neurobehavioural Performance, Polysomnography, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, University of Manitoba, Swedish National Road and Transport Research Institute
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, the investigators will play synthesised automotive tyre sounds, investigating how acoustical characteristics of tyre noise impact on sleep macrostructure, cardiometabolic profile and cognitive performance (continuous traffic flow or a few individual, but higher level, traffic pass-bys). The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analysed to identify metabolic changes in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which chronic noise exposure at night can lead to the development of diseases in the long term, especially cardiometabolic disorders.
Detailed description
The experimental sleep study has the overarching goal of deepening our understanding of sleep disruption by automotive tyre noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following independent aims:
Aim 1: Determine the biological and neurobehavioural consequences of sleep disruption by tyre noise. The investigators will measure the sleep of healthy volunteers, and each morning the investigators will obtain blood samples for metabolomics analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics and cognitive function between quiet nights and nights with road traffic noise.
Aim 2: Identify acoustical characteristics of tyre noise that are especially disturbing physiologically. The investigators will use different combinations of types of tyre noise in different noise exposure nights to determine differential effects on sleep and cardiovascular response.
This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine (Arbets- och miljömedicin [AMM]). The SEL is a high fidelity research laboratory equipped to simulate a typical apartment, including three individually light-, sound- and vibration-isolated private bedrooms. Ceiling mounted speakers in each room allow the investigators to create a realistic acoustic environment by transmitting sound exposures from the control room to each bedroom individually. The investigators have shown previously that results from this lab with high ecological validity are comparable with results from the field.
There will be two study arms, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. Participants (study 1 N=15; study 2 N=30; total N=45 across both arms) will each spend six consecutive nights in the SEL, with a sleep opportunity between 23:00-07:00. Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist actigraphy monitors worn continuously throughout the study. Three subjects will take part concurrently, in separate bedrooms. The first night is a habituation period to the study protocol and for familiarisation with the test procedures. Study nights 2-6 are the experimental nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to each of the following:
One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance;
Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that the investigators can examine each combination of two specific noise characteristics.
Each night the investigators will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 4 ml blood sample, complete cognitive testing and answer questionnaires and will depart the SEL to follow their normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at all times. Because extreme and/or variable dietary behaviour can affect the metabolome/lipoprotein profile, participants will be given guidance that they should eat a similar evening meal on each day of the laboratory study, confirmed with a food diary, The actual meal itself can be different for different study participants, because the study has a within-subjects design.
Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto the sleep recorder, and will be downloaded and checked every study morning to ensure data quality. In addition to traditional sleep analysis performed by the research group at the University of Gothenburg, raw PSG data will be used to calculate the Odds Ratio Project, a novel metric of sleep depth and stability.
Each study morning subjects will provide a 4 ml blood sample for plasma metabolomics analysis. To ensure reliable data, blood samples will be taken at the same time every day to mitigate circadian effects, before eating or drinking anything except water, and each sample will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers. Subjects will eat the same food each study evening to mitigate within-subject dietary effects on the blood metabolome.
Each morning, subjects will complete a computerised cognitive test battery taking approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance). Cognition data will be analysed to determine key measures of cognitive speed and accuracy, adjusting for practice effects and the difficulty of the stimulus set.
Subjects will complete a battery of one-time validated questionnaires to measure their general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a questionnaire each study evening and morning, involving questions on sleepiness (Karolinska Sleepiness Scale), sleep disturbance by noise, positive and negative affect (PANAS), and validated sleep and disturbance questions.
Participants will wear a wrist actigraphy monitor continuously throughout the study period, and also for the week before the study, to confirm habitual sleep-wake times and to measure physical activity levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
- Model description
- There will be two separate study periods, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. The order of the noise exposure conditions will be be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to one night of each of the following: One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance; Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that we can examine each combination of two specific noise characteristics.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Single study night with no noise exposure, to determine normal baseline sleep |
| Study 1: High level continuous flow tyre noise (A1) | Experimental | Radiation: Tyre noise - continuous flow, Radiation: High noise levelSingle study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by high level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. |
| Study 1: Medium level continuous flow tyre noise (B1) | Experimental | Radiation: Tyre noise - continuous flow, Radiation: Moderate noise levelSingle study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. |
| Study 1: High level, discrete traffic tyre noise (A2) | Experimental | Radiation: Tyre noise - discrete events, Radiation: High noise levelSingle study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by high level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. |
| Study 1: Medium level, discrete traffic tyre noise (B2) | Experimental | Radiation: Tyre noise - discrete events, Radiation: Moderate noise levelSingle study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by moderate level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night. |
| Study 2: Medium level composite wheel tyre noise (A1) | Experimental | Radiation: Moderate noise level, Radiation: Composite tyresSingle study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of composite wheel types. |
| Study 2: Low level composite wheel tyre noise (B1) | Experimental | Radiation: Low noise level, Radiation: Composite tyresSingle study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of composite wheel types. |
| Study 2: Medium level air-filled tyre noise (A2) | Experimental | Radiation: Moderate noise level, Radiation: Air-filled tyresSingle study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of traditional air-filled wheel types. |
| Study 2: Low level air-filled tyre noise (B2) | Experimental | Radiation: Low noise level, Radiation: Air-filled tyresSingle study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of traditional air-filled wheel types. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. live in or around the city of Gothenburg area (Sweden)
Key exclusion criteria (9 listed)
- aged <18 or >30 years;
- habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00);
- BMI>25 kg/m2;
- regular sleep medication use (prescribed or "over-the-counter");
- poor hearing acuity (measured during screening via pure tone audiometry);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tyre noise - continuous flowTyre noise from continuous traffic, throughout the night | Radiation | Study 1: High level continuous flow tyre noise (A1), Study 1: Medium level continuous flow tyre noise (B1) |
| Tyre noise - discrete eventsTyre noise from few, discrete traffic events, occurring throughout the night | Radiation | Study 1: High level, discrete traffic tyre noise (A2), Study 1: Medium level, discrete traffic tyre noise (B2) |
| High noise levelTyre noise corresponding up to 65 dB LAEq,24h | Radiation | Study 1: High level continuous flow tyre noise (A1), Study 1: High level, discrete traffic tyre noise (A2) |
| Moderate noise levelTyre noise corresponding up to 60 dB LAEq,24h | Radiation | Study 1: Medium level continuous flow tyre noise (B1), Study 1: Medium level, discrete traffic tyre noise (B2), Study 2: Medium level air-filled tyre noise (A2), Study 2: Medium level composite wheel tyre noise (A1) |
| Low noise levelTyre noise corresponding up to 55 dB LAEq,24h | Radiation | Study 2: Low level air-filled tyre noise (B2), Study 2: Low level composite wheel tyre noise (B1) |
| Air-filled tyresTyre noise from traditional, air-filled tyres | Radiation | Study 2: Low level air-filled tyre noise (B2), Study 2: Medium level air-filled tyre noise (A2) |
| Composite tyresTyre noise from newly designed, airless composite tyres | Radiation | Study 2: Low level composite wheel tyre noise (B1), Study 2: Medium level composite wheel tyre noise (A1) |
Primary outcome
Baseline total sleep time during the Control night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the A1 night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the A2 night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the B1 night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the B2 night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination A1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination A2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination B1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination B2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N1 sleep during the Control night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N2 sleep during the Control night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N3 sleep during the Control night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline rapid eye movement (REM) sleep during the Control night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline wakefulness after sleep onset (WASO) during the Control night
Time frame: One night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A1
Time frame: One night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A2
Time frame: One night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B1
Time frame: One night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B2
Time frame: One night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline number of awakenings during the Control night
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination A1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination A2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination B1
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination B2
Time frame: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline sleep onset latency (SOL) during the Control night
Time frame: One night
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A1
Time frame: One night
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A2
Time frame: One night
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B1
Time frame: One night
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B2
Time frame: One night
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Baseline sleep efficiency during the Control night
Time frame: One night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination A1
Time frame: One night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination A2
Time frame: One night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination B1
Time frame: One night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination B2
Time frame: One night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Baseline sleep depth assessed using the odds ratio product (ORP) during the Control night
Time frame: One night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A1
Time frame: One night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A2
Time frame: One night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B1
Time frame: One night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B2
Time frame: One night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Spontaneous maximal change of odds ratio product (ORP) during the Control night
Time frame: One night
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over 120 sham noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A1
Time frame: One night
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A2
Time frame: One night
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B1
Time frame: One night
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B2
Time frame: One night
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Morning neurobehavioural speed in the morning immediately after the Control night
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the A1 night
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the A2 night
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the B1 night
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the B2 night
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after the control night
Time frame: One night
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A1
Time frame: One night
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A2
Time frame: One night
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B1
Time frame: One night
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B2
Time frame: One night
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Baseline evening neurobehavioural speed following the Control night
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A1
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A2
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B1
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B2
Time frame: One night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Baseline evening neurobehavioural accuracy following the Control night
Time frame: One night
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A1
Time frame: One night
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A2
Time frame: One night
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B1
Time frame: One night
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B2
Time frame: One night
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Event-related Cardiovascular activation in response to noise during Control night
Time frame: One night
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during A1
Time frame: One night
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during A2
Time frame: One night
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during B1
Time frame: One night
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during B2
Time frame: One night
Change in heart rate (ECG)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the control night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A1 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A2 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B1 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B2 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the control night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A1 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A2 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B1 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B2 night
Time frame: One night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Taurine concentration (mmol/L) immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Leucine concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Valine concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Phenylalanine concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L)In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Basline Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Baseline Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Control night
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Time frame: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Time frame: One night
Determined from GC-MS analysis of blood plasma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G Smith, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tyre noise - continuous flow, Tyre noise - discrete events and High noise level in people with Noise Exposure and Sleep Disturbance, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline total sleep time during the Control night (time frame: One night). The study lists 179 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.