Noise ExposureNCT06466668
De Oorzaak: Citizen Science Project on the Impact of Environmental Noise
An observational study of Noise Exposure and Sleep, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
"De Oorzaak" is a large-scale citizen science project aiming to assess the impact of environmental sounds on the quality of life. This particular study is a part of a broader citizen science research project "De Oorzaak", which focuses on mapping the effects of ambient noise with high resolution and on a large scale… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure, Sleep, Hyperacusis
- What is being tested?
- Sleep study, stress-related biomarkers and microbiome composition will be assessed using saliva samples and Audiological tests
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Apr 2024to 31 Oct 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healty population representing the citizens of Antwerp with an equal distribution between those with and without increased sensitivity to ambient noise.
Who may be able to join
- Adults (age 18 years old and above)
- Both male and female citizens
- Living in Antwerp
- Bedroom window allows positioning of sound sensor
- Indicated in preliminary questionnaires to be interested and willing to participate in the medical trajectory medical trajectory (i.e. sleep study, saliva sample and audiological testing)
- Equal distribution between citizens reporting both increased as decreased nuisance due to ambient noise ambient noise
- Equal distribution of participants reporting a high or low impact on their sleep quality due to Equal distribution of participants reporting a high or low impact on their sleep quality due to nighttime environmental noise
Who cannot join
- Known chronic medical conditions
- Smoking
- Bad self-reported health condition
- Diagnosed chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: De Oorzaak: Impact of Environmental Noise on Sleep Quality and Stress, and the Role of Auditive Sensitivity in This
"De Oorzaak" is a large-scale citizen science project aiming to assess the impact of environmental sounds on the quality of life. This particular study is a part of a broader citizen science research project "De Oorzaak", which focuses on mapping the effects of ambient noise with high resolution and on a large scale across Flanders. The specific goal of the underlying sub study is to expand our current knowledge of how ambient noise affects sleep quality and stress.
Read the detailed description
The literature identifies both factors as crucial aspects of health and quality of life that are strongly influenced by ambient noise. However, it is often complex to establish a direct connection between these factors.
Sound has a significant impact on both sleep quality and quality of life. A calm, quiet environment is essential for a good night's sleep since sounds can cause interference and induce sleep disturbances. External noise, such as traffic, neighbours or city activities, can result in sleep disturbances and fatigue. In addition, sudden, loud noises such as sirens can interrupt sleep cycles, further negatively affecting the depth and quality of sleep. Furthermore, recent research demonstrated an increase in stress biomarkers in saliva during various stress conditions, including noise pollution in urban environments, as well as disruptions to the microbiome and increases in inflammatory biomarkers in saliva due to stress. However, it is challenging to directly attribute this disruption of sleep quality and increased stress levels to noise. Research often relies on participant self-reporting. "De Oorzaak" offers a unique opportunity to link sleep quality and stress (via a medical assessment) directly to environmental noise (objectivized using a sound sensor outside the bedroom window), while correcting for participants' sensitivity to it.
In order to do so, 2400 advanced sound sensors will be installed at bedroom windows of citizens across Antwerp, Ghent and Leuven to objectivize the sound landscape in these cities. Additionally, a detailed medical assessment is employed to objectivize the impact of sound on the quality of life in a subset of 120 citizens in the city of Antwerp. The goal of this assessment is to obtain an objective evaluation of sleep quality and stress and the potential association to individual oversensitivity to sound in citizens whose bedroom is located at the street side. In order to do so, citizens will be submitted to a remote sleep study with electrodes registering brain and muscle activity to determine different sleep stages as well as the potential sound-induced disruption thereof. Additionally, saliva samples will be collected to objectivize the stress experiences by the citizen involved in this project. Finally, an audiological assessment will be performed to evaluate the dynamical range of hearing thresholds and uncomfortable levels of loudness. By assessing these parameters a comparison can be made between citizens with and without hyperacusis (i.e. intolerance for daily sounds), subsequently it will be assessed whether this "sound sensitivity" results in a difference in sleep quality and stress.
- Conditions
- Noise Exposure, Sleep, Hyperacusis
- Being tested
- Sleep study, stress-related biomarkers and microbiome composition will be assessed using saliva samples, Audiological tests
- Medical subject headings
- Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep studyDiagnostic test
All subjects will undergo a polysomnography at home
stress-related biomarkers and microbiome composition will be assessed using saliva samplesDiagnostic test
stress and stress-related inflammatory biomarkers will be tested using saliva sample
Audiological testsDiagnostic test
Pure tone audiometry, Uncomfortable Loudness Levels, Distortion-Product Otoacoustic Emissions, tablet test for hyperacusis, tablet test for hearing screening
| Study group | Role | What they receive |
|---|---|---|
| Hyperacusis | participants with hyperacusis (or an increased sensitivity to sound) Receives: Diagnostic Test: Sleep study; Diagnostic Test: stress-related biomarkers and microbiome composition will be assessed using saliva samples; Diagnostic Test: Audiological tests | |
| No hyperacusis | participants without hyperacusis (or an increased sensitivity to sound) Receives: Diagnostic Test: Sleep study; Diagnostic Test: stress-related biomarkers and microbiome composition will be assessed using saliva samples; Diagnostic Test: Audiological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound-induced sleep disturbances
Polysomnographic analysis of the sleep to incedence of (micro)arousals. Using a class I sound sensor it will be assessed whether and which sounds are present at the time of these arousals.
Measured: Single time point (before December 31 2025)
Secondary outcomes (2)
Differences in the levels of stress-related biomarkers in saliva
Quantification of hormones (e.g., cortisol) and cytokines (e.g., IL-8) by ELISA
Measured: Single time point before sleep analysis
Differences in salivary microbiome composition
Amplicon sequencing with the Illumina MiSeq
Measured: Single time point before sleep analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start29 Apr 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
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 University Hospital, AntwerpThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466668
- Sponsor's protocol ID
- B3002024000055
- Status last verified
- Mar 2024
- First submitted
- 13 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De Oorzaak: Impact of Environmental Noise on Sleep Quality and Stress, and the Role of Auditive Sensitivity in This
- ClinicalTrials.gov ID
- NCT06466668
- Acronym / sponsor ID
- B3002024000055
- Conditions
- Noise Exposure, Sleep, Hyperacusis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 20 Jun 2024 (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.
"De Oorzaak" is a large-scale citizen science project aiming to assess the impact of environmental sounds on the quality of life. This particular study is a part of a broader citizen science research project "De Oorzaak", which focuses on mapping the effects of ambient noise with high resolution and on a large scale across Flanders. The specific goal of the underlying sub study is to expand our current knowledge of how ambient noise affects sleep quality and stress.
Detailed description
The literature identifies both factors as crucial aspects of health and quality of life that are strongly influenced by ambient noise. However, it is often complex to establish a direct connection between these factors.
Sound has a significant impact on both sleep quality and quality of life. A calm, quiet environment is essential for a good night's sleep since sounds can cause interference and induce sleep disturbances. External noise, such as traffic, neighbours or city activities, can result in sleep disturbances and fatigue. In addition, sudden, loud noises such as sirens can interrupt sleep cycles, further negatively affecting the depth and quality of sleep. Furthermore, recent research demonstrated an increase in stress biomarkers in saliva during various stress conditions, including noise pollution in urban environments, as well as disruptions to the microbiome and increases in inflammatory biomarkers in saliva due to stress. However, it is challenging to directly attribute this disruption of sleep quality and increased stress levels to noise. Research often relies on participant self-reporting. "De Oorzaak" offers a unique opportunity to link sleep quality and stress (via a medical assessment) directly to environmental noise (objectivized using a sound sensor outside the bedroom window), while correcting for participants' sensitivity to it.
In order to do so, 2400 advanced sound sensors will be installed at bedroom windows of citizens across Antwerp, Ghent and Leuven to objectivize the sound landscape in these cities. Additionally, a detailed medical assessment is employed to objectivize the impact of sound on the quality of life in a subset of 120 citizens in the city of Antwerp. The goal of this assessment is to obtain an objective evaluation of sleep quality and stress and the potential association to individual oversensitivity to sound in citizens whose bedroom is located at the street side. In order to do so, citizens will be submitted to a remote sleep study with electrodes registering brain and muscle activity to determine different sleep stages as well as the potential sound-induced disruption thereof. Additionally, saliva samples will be collected to objectivize the stress experiences by the citizen involved in this project. Finally, an audiological assessment will be performed to evaluate the dynamical range of hearing thresholds and uncomfortable levels of loudness. By assessing these parameters a comparison can be made between citizens with and without hyperacusis (i.e. intolerance for daily sounds), subsequently it will be assessed whether this "sound sensitivity" results in a difference in sleep quality and stress.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperacusis | – | Diagnostic Test: Sleep study, Diagnostic Test: stress-related biomarkers and microbiome composition will be assessed using saliva samples, Diagnostic Test: Audiological testsparticipants with hyperacusis (or an increased sensitivity to sound) |
| No hyperacusis | – | Diagnostic Test: Sleep study, Diagnostic Test: stress-related biomarkers and microbiome composition will be assessed using saliva samples, Diagnostic Test: Audiological testsparticipants without hyperacusis (or an increased sensitivity to sound) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healty population representing the citizens of Antwerp with an equal distribution between those with and without increased sensitivity to ambient noise.
Key inclusion criteria (7 listed)
- Adults (age 18 years old and above)
- Both male and female citizens
- Living in Antwerp
- Bedroom window allows positioning of sound sensor
- Indicated in preliminary questionnaires to be interested and willing to participate in the medical trajectory medical trajectory (i.e. sleep study, saliva sample and audiological testing)
Key exclusion criteria (4 listed)
- Known chronic medical conditions
- Smoking
- Bad self-reported health condition
- Diagnosed chronic diseases
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 |
|---|---|---|
| Sleep studyAll subjects will undergo a polysomnography at home | Diagnostic test | Hyperacusis, No hyperacusis |
| stress-related biomarkers and microbiome composition will be assessed using saliva samplesstress and stress-related inflammatory biomarkers will be tested using saliva sample | Diagnostic test | Hyperacusis, No hyperacusis |
| Audiological testsPure tone audiometry, Uncomfortable Loudness Levels, Distortion-Product Otoacoustic Emissions, tablet test for hyperacusis, tablet test for hearing screening | Diagnostic test | Hyperacusis, No hyperacusis |
Primary outcome
Sound-induced sleep disturbances
Time frame: Single time point (before December 31 2025)
Polysomnographic analysis of the sleep to incedence of (micro)arousals. Using a class I sound sensor it will be assessed whether and which sounds are present at the time of these arousals.
2 secondary outcomes
Differences in the levels of stress-related biomarkers in saliva
Time frame: Single time point before sleep analysis
Differences in salivary microbiome composition
Time frame: Single time point before sleep analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise Exposure and Sleep, run by University Hospital, Antwerp at 1 site in Belgium.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jun 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 Belgium. 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?
Results are not available in the source record.
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?
Sound-induced sleep disturbances (time frame: Single time point (before December 31 2025)). 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 20 Jun 2024.