AzTrials
AzTrials

Noise ExposureBioVibNCT06260254

Effects of Railway Vibration on Sleep and Disease

A study testing Railway noise, Low level railway vibration and Intermediate level railway vibration in people with Noise Exposure and Sleep Disturbance, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. 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?
Railway noise, Low level railway vibration and Intermediate level railway vibration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteSweden
Study dates
5 Feb 2024to 31 Oct 2024
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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  • diagnosed with diabetes
  • indications of sleep apnea on the STOP-BANG questionnaire;
  • shift work;
  • smoking, vaping, snus, or other nicotine use;
  • pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • University of Gothenburg

    Gothenburg, Västra Götaland County, 42650

Other trials in Sweden

About this study

This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. 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 analyzed to identify metabolic changes and indicators of diabetes risk in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which railway vibration exposure at night can lead to the development of diseases in the long term, especially metabolic disorders including diabetes.

Read the detailed description

The experimental sleep study has the overarching goal of deepening understanding of sleep disruption by railway vibration and noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following study aim:

Aim 1: Determine the biological and neurobehavioral consequences of sleep disruption by railway vibration. The investigators will measure the sleep of healthy volunteers, and each morning will obtain blood samples for metabolomics metabolic function analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics, metabolic function and cognitive function between quiet nights and nights with railway traffic vibration and noise. Dose-response relationships will be determined by comparing nights with different levels of vibration.

This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine. 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 and electrodynamic transducers mounted to the underside of each bed allow the investigators to create a realistic acoustic environment by transmitting sound and vibration 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.

This study has a prospective within-subjects cross-over design. Participants (total N=24) will each spend five 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 familiarization with the test procedures. The second night will be a quiet condition without noise or vibration, to determine normal baseline sleep, cardiometabolic profile, and cognitive performance. Study nights 3-5 are the vibration nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. In these vibration nights, vibration and noise from railway freight will be played into the bedrooms to determine the effects of vibration and noise on sleep, cardiometabolic function and cognitive performance. Thirty six trains will occur each night, randomly distributed across the 8-hour sleep period.

For railway vibration the investigators will use synthesized signals based on measured data, used in previous laboratory studies. It is necessary to use synthesized vibration, rather than recorded signals, so that the investigators can accurately adjust the acoustical character of the exposure as needed. Railway vibration will be accompanied by high fidelity recordings of railway freight noise. This is to maximize ecological validity of the exposures since vibration rarely occurs without noise, and to mask any mechanical sounds from the vibration transducers.

Vibration and noise exposures will reflect realistic railway freight traffic noise levels that occur in dwellings alongside railway lines in Sweden. The maximum Wm-weighted vibration amplitudes in the three vibration nights will be 0.5 mm/s, 0.7 mm/s and 0.9 mm/s respectively. Maximum sound pressure levels of individual train passages will not exceed 49.8 dB LAF,max. Trains will vary from 11.5 s to 56.9 s in duration. All vibration amplitudes will be calibrated on the mattress of the bed, under a 75 kg reference weight to simulate the bed being occupied. All sound pressure levels will be calibrated to 10 cm above the pillow in each bedroom prior to the study, so that these levels accurately reflect the noise exposure of the subjects during sleep.

Each night the investigators will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 2ml blood sample 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 behavior 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, 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 2 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. Furthermore, a 2-hour oral glucose tolerance test (OGTT) will be performed in the mornings after the quiet control night (i.e. after study night 2) and after the third vibration exposure night (i.e. after study night 5). The investigators will measure response to a 75g glucose bolus at timepoints 10, 20, 30, 60, 90 and 120 minutes after the glucose administration.

Each evening, subjects will complete a computerized 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 analyzed 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), auditory fatigue, sleep disturbance by noise, and validated sleep and disturbance questions.

Being tested
Railway noise, Low level railway vibration, Intermediate level railway vibration, High level railway vibration
Keywords
neurobehavioral performance, Traffic noise, auditory fatigue, polysomnography, metabolomics, vibration
Medical subject headings
Parasomnias, Sleep Hygiene, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Railway noiseRadiation

    Low level railway noise, not exceeding 50 dB LAF,max. Thirty six single railway noise events.

  • Low level railway vibrationRadiation

    36 single railway noise events at 0.5 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

  • Intermediate level railway vibrationRadiation

    36 single railway noise events at 0.7 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

  • High level railway vibrationRadiation

    36 single railway noise events at 0.9 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

Study groups in NCT06260254
Study groupRoleWhat they receive
Control NightNo interventionSingle study night with no noise exposure, to determine normal baseline sleep.
Low Vibration NightExperimentalSingle study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at a lower level
Receives: Radiation: Railway noise; Radiation: Low level railway vibration
Intermediate Vibration NightExperimentalSingle study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at an intermediate level
Receives: Radiation: Railway noise; Radiation: Intermediate level railway vibration
High Vibration NightExperimentalSingle study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at a higher level
Receives: Radiation: Railway noise; Radiation: High level railway vibration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting insulin resistance in the morning immediately after the Control night

    Calculated using the Homeostatic model of insulin resistance (HOMA-IR)

    Measured: One night

  2. Fasting insulin resistance in the morning immediately after the low vibration night

    Calculated using the Homeostatic model of insulin resistance (HOMA-IR)

    Measured: One night

  3. Fasting insulin resistance in the morning immediately after the intermediate vibration night

    Calculated using the Homeostatic model of insulin resistance (HOMA-IR)

    Measured: One night

  4. Fasting insulin resistance in the morning immediately after the high vibration night

    Calculated using the Homeostatic model of insulin resistance (HOMA-IR)

    Measured: One night

  5. Total sleep time during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  6. Total sleep time during the low vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  7. Total sleep time during the intermediate vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  8. Total sleep time during the high vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  9. Total amount of N1 sleep during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  10. Total amount of N2 sleep during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  11. Total amount of N3 sleep during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  12. Total amount of 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

  13. Total amount of N1 sleep during the low vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  14. Total amount of N2 sleep during the low vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  15. Total amount of N3 sleep during the low vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  16. Total amount of rapid eye movement (REM) sleep during the low vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  17. Total amount of N1 sleep during the intermediate vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  18. Total amount of N2 sleep during the intermediate vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  19. Total amount of N3 sleep during the intermediate vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  20. Total amount of rapid eye movement (REM) sleep during the intermediate vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  21. Total amount of N1 sleep during the high vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  22. Total amount of N2 sleep during the high vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  23. Total amount of N3 sleep during the high vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  24. Total amount of rapid eye movement (REM) sleep during the high vibration night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    Measured: One night

  25. 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

  26. Wakefulness after sleep onset (WASO) during the low vibration 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

  27. Wakefulness after sleep onset (WASO) during the intermediate 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

  28. Wakefulness after sleep onset (WASO) during the high vibration 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

  29. Number of awakenings during the Control night

    Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.

    Measured: One night

  30. Number of awakenings during exposure to low vibration

    Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.

    Measured: One night

  31. Number of awakenings during exposure to intermediate vibration

    Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.

    Measured: One night

  32. Number of awakenings during exposure to high vibration

    Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.

    Measured: One night

  33. 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

  34. Sleep onset latency (SOL) during the low vibration 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

  35. Sleep onset latency (SOL) during the intermediate vibration 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

  36. Sleep onset latency (SOL) during the high vibration 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

  37. 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

  38. Sleep efficiency during the low vibration 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

  39. Sleep efficiency during the intermediate vibration 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

  40. S Sleep efficiency during the high vibration 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

  41. 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

  42. Sleep depth assessed using the odds ratio product (ORP) during the low vibration 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

  43. Sleep depth assessed using the odds ratio product (ORP) during the intermediate vibration 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

  44. Sleep depth assessed using the odds ratio product (ORP) during the high vibration 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

  45. Maximal change of odds ratio product (ORP) during exposure to railway vibration events

    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 railway vibration. Averaged over 36 vibration events during the night.

    Measured: One night

  46. Area under the curve of odds ratio product (ORP) during exposure to railway vibration events, calculated using the trapezoid rule

    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 railway vibration. Averaged over 36 vibration events during the night.

    Measured: One night

  47. N-acetylglucosamine/galactosamine (GlycA) concentration after the Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  48. N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  49. N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to intermediate vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  50. N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to high vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  51. Sialic acid (GlycB) concentration after the Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  52. Sialic acid (GlycB) concentration after exposure to low vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  53. Sialic acid (GlycB) concentration after exposure to intermediate vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  54. Sialic acid (GlycB) concentration after exposure to high vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  55. Supramolecular phospholipid composite (SPC) concentration after the Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  56. Supramolecular phospholipid composite (SPC) concentration after exposure to low vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  57. Supramolecular phospholipid composite (SPC) concentration after exposure to intermediate vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  58. Supramolecular phospholipid composite (SPC) concentration after exposure to high vibration

    Determined from NMR analysis of blood plasma

    Measured: One night

  59. Ethanol concentration (mmol/L) after the Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  60. Ethanol concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  61. Ethanol concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  62. Ethanol concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  63. Trimethylamine-N-oxide concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  64. Trimethylamine-N-oxide concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  65. Trimethylamine-N-oxide concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  66. Trimethylamine-N-oxide concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  67. 2-Aminobutyric acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One

  68. 2-Aminobutyric acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One

  69. 2-Aminobutyric acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One

  70. 2-Aminobutyric acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One

  71. Alanine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  72. Alanine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  73. Alanine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  74. Alanine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  75. Asparagine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  76. Asparagine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  77. Asparagine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  78. Asparagine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  79. Creatine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  80. Creatine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  81. Creatine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  82. Creatine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  83. Creatinine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  84. Creatinine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  85. Creatinine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  86. Creatinine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  87. Glutamic acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  88. Glutamic acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  89. Glutamic acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  90. Glutamic acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  91. Glutamine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  92. Glutamine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  93. Glutamine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  94. Glutamine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  95. Glycine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  96. Glycine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  97. Glycine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  98. Glycine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  99. Histidine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  100. Histidine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  101. Histidine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  102. Histidine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  103. Isoleucine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  104. Isoleucine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  105. Isoleucine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  106. Isoleucine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  107. Leucine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  108. Leucine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  109. Leucine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  110. Leucine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  111. Lysine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  112. Lysine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  113. Lysine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  114. Lysine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  115. Methionine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  116. Methionine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  117. Methionine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  118. Methionine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  119. N,N-Dimethylglycine concentration (mmol/L) after Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  120. N,N-Dimethylglycine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  121. N,N-Dimethylglycine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  122. N,N-Dimethylglycine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  123. Ornithine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  124. Ornithine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  125. Ornithine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  126. Ornithine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  127. Phenylalanine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  128. Phenylalanine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  129. Phenylalanine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  130. Phenylalanine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  131. Proline concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  132. Proline concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  133. Proline concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  134. Proline concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  135. Sarcosine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  136. Sarcosine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  137. Sarcosine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  138. Sarcosine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  139. Threonine concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  140. Threonine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  141. Threonine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  142. Threonine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  143. Tyrosine concentration (mmol/L) after exposure toControl night

    Determined from NMR analysis of blood plasma

    Measured: One night

  144. Tyrosine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  145. Tyrosine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  146. Tyrosine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  147. Valine concentration (mmol/L) after Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  148. Valine concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  149. Valine concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  150. Valine concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  151. 2-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  152. 2-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  153. 2-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  154. 2-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  155. Acetic acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  156. Acetic acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  157. Acetic acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  158. Acetic acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  159. Citric acid concentration (mmol/L) after Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  160. Citric acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  161. Citric acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  162. Citric acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  163. Formic acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  164. Formic acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  165. Formic acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  166. Formic acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  167. Lactic acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  168. Lactic acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  169. Lactic acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  170. Lactic acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  171. Succinic acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  172. Succinic acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  173. Succinic acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  174. Succinic acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  175. Choline concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  176. Choline concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  177. Choline concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  178. Choline concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  179. 2-Oxoglutaric acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  180. 2-Oxoglutaric acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  181. 2-Oxoglutaric acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  182. 2-Oxoglutaric acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  183. 3-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  184. 3-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  185. 3-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  186. 3-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  187. Acetoacetic acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  188. Acetoacetic acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  189. Acetoacetic acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  190. Acetoacetic acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  191. Acetone concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  192. Acetone concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  193. Acetone concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  194. Acetone concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  195. Pyruvic acid concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  196. Pyruvic acid concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  197. Pyruvic acid concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  198. Pyruvic acid concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  199. D-Galactose concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  200. D-Galactose concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  201. D-Galactose concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  202. D-Galactose concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  203. Glucose concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  204. Glucose concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  205. Glucose concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  206. Glucose concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  207. Glycerol concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  208. Glycerol concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  209. Glycerol concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  210. Glycerol concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  211. Dimethylsulfone concentration (mmol/L) after exposure to Control night

    Determined from NMR analysis of blood plasma

    Measured: One night

  212. Dimethylsulfone concentration (mmol/L) after exposure to low vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  213. Dimethylsulfone concentration (mmol/L) after exposure to intermediate vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  214. Dimethylsulfone concentration (mmol/L) after exposure to high vibration night

    Determined from NMR analysis of blood plasma

    Measured: One night

  215. Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the control night

    Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.

    Measured: One night

  216. Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the low vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.

    Measured: One night

  217. Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the intermediate vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.

    Measured: One night

  218. Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the high vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.

    Measured: One night

  219. Response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus

    Measured: One night

  220. Response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus

    Measured: One night

  221. Response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus

    Measured: One night

  222. Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the control night

    Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus

    Measured: One night

  223. Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus

    Measured: One night

  224. Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus

    Measured: One night

  225. Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night

    Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus

    Measured: One night

  226. Glucose tolerance in the morning after exposure to low vibration, assessed as glucose concentration 120 minutes after a glucose bolus

    Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method

    Measured: One night

  227. Glucose tolerance in the morning after exposure to intermediate vibration, assessed as glucose concentration 120 minutes after a glucose bolus

    Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method

    Measured: One night

  228. Glucose tolerance in the morning after exposure to high vibration, assessed as glucose concentration 120 minutes after a glucose bolus

    Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method

    Measured: One night

  229. Glucose tolerance in the morning after Control night, assessed as glucose concentration 120 minutes after a glucose bolus

    Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method

    Measured: One night

  230. Stumvoll Insulin sensitivity Index in the morning after control

    .226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.

    Measured: One night

  231. Stumvoll Insulin sensitivity Index in the morning after exposure to low vibration

    .226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.

    Measured: One night

  232. Stumvoll Insulin sensitivity Index in the morning after exposure to intermediate vibration

    .226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.

    Measured: One night

  233. Stumvoll Insulin sensitivity Index in the morning after exposure to high vibration

    .226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.

    Measured: One night

  234. Matsuda insulin sensitivity index in the morning after control exposure

    Calculated as 10,000/square root of [fasting glucose × fasting insulin] × [mean glucose × mean insulin during oral glucose tolerance test])

    Measured: One night

  235. Matsuda insulin sensitivity index in the morning after exposure to low vibration

    Calculated as 10,000/square root of [fasting glucose × fasting insulin] × [mean glucose × mean insulin during oral glucose tolerance test])

    Measured: One night

  236. Matsuda insulin sensitivity index in the morning after exposure to intermediate vibration

    Calculated as 10,000/square root of [fasting glucose × fasting insulin] × [mean glucose × mean insulin during oral glucose tolerance test])

    Measured: One night

  237. Matsuda insulin sensitivity index in the morning after exposure to high vibration

    Calculated as 10,000/square root of [fasting glucose × fasting insulin] × [mean glucose × mean insulin during oral glucose tolerance test])

    Measured: One night

Secondary outcomes (34)
  1. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control

    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

  2. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration

    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

  3. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration

    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

  4. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration

    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

  5. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control

    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

  6. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration

    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

  7. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration

    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

  8. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration

    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

  9. Self-reported sleep disturbance by vibration after control exposure

    Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"

    Measured: One night

  10. Self-reported sleep disturbance by vibration after exposure to low vibration

    Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"

    Measured: One night

  11. Self-reported sleep disturbance by vibration after exposure to intermediate vibration

    Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"

    Measured: One night

  12. Self-reported sleep disturbance by vibration after exposure to high vibration

    Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"

    Measured: One night

  13. Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  14. Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  15. Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  16. Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  17. Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  18. Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  19. Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  20. Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  21. Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  22. Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  23. Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  24. Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  25. Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  26. Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  27. Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  28. Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration

    PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely". A composite positive affect score is calculated from 10 of these.

    Measured: One night.

  29. Event-related cardiovascular activation in response to control

    Change in heart rate (ECG)

    Measured: One night

  30. Event-related cardiovascular activation in response to low vibration

    Change in heart rate (ECG)

    Measured: One night

  31. Event-related cardiovascular activation in response to intermediate vibration

    Change in heart rate (ECG)

    Measured: One night

  32. Event-related cardiovascular activation in response to high vibration

    Change in heart rate (ECG)

    Measured: One night

  33. Evening neurobehavioural speed

    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

  34. Evening neurobehavioural accuracy

    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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start5 Feb 2024
  3. Primary completion14 Jun 2024
  4. Study completion31 Oct 2024

Resources

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
All participants will be exposed to each of the different vibration conditions. Each study night is treated as a separate arm of the crossover study. The order of the vibration 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: Quiet night: No noise or vibration will be played, serving as a control night to assess individual baseline sleep, metabolic profile, and cognitive performance; Three railway vibration nights to determine consequences of noise-disrupted sleep. The vibration level in these three nights will be 0.5 mm/s, 0.7 mm/s and 0.9 mm/s respectively, so that exposure-response relationships can be derived.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06260254
Sponsor's protocol ID
244826201
Acronym
BioVib
Status last verified
Mar 2025
First submitted
7 Feb 2024
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Railway noise, Low level railway vibration and Intermediate level railway vibration 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 11 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 13 Mar 2025. 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?

Fasting insulin resistance in the morning immediately after the Control night (time frame: One night). The study lists 237 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 13 Mar 2025.

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