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Enrolling by invitationNCT06466668Updated Jun 20, 2024

De Oorzaak: Citizen Science Project on the Impact of Environmental Noise

An observational study in Noise Exposure, Sleep and Hyperacusis, sponsored by University Hospital, Antwerp. Enrolling by invitation at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by University Hospital, Antwerp · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Noise Exposure
  • Sleep
  • Hyperacusis

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03

In context

Hyperacusis

32 studies on the registry are indexed under Hyperacusis; 9 are open to participants now.

Browse Hyperacusis studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healty population representing the citizens of Antwerp with an equal distribution between those with and without increased sensitivity to ambient noise.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Known chronic medical conditions
  • Smoking
  • Bad self-reported health condition
  • Diagnosed chronic diseases
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Hyperacusis

    participants with hyperacusis (or an increased sensitivity to sound)

    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)

    Diagnostic Test: Sleep study · Diagnostic Test: stress-related biomarkers and microbiome composition will be assessed using saliva samples · Diagnostic Test: Audiological tests

Interventions

  • Diagnostic testSleep study

    All subjects will undergo a polysomnography at home

  • Diagnostic teststress-related biomarkers and microbiome composition will be assessed using saliva samples

    stress and stress-related inflammatory biomarkers will be tested using saliva sample

  • Diagnostic testAudiological tests

    Pure tone audiometry, Uncomfortable Loudness Levels, Distortion-Product Otoacoustic Emissions, tablet test for hyperacusis, tablet test for hearing screening

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Single time point (before December 31 2025)

Secondary outcomes

  1. Differences in the levels of stress-related biomarkers in saliva

    Quantification of hormones (e.g., cortisol) and cytokines (e.g., IL-8) by ELISA

    Time frame: Single time point before sleep analysis

  2. Differences in salivary microbiome composition

    Amplicon sequencing with the Illumina MiSeq

    Time frame: Single time point before sleep analysis

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2024 (actual). Primary completion is estimated for Oct 2025, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2024
First posted
Jun 20, 2024
StartActual
Apr 29, 2024
Primary completionEst.
Oct 31, 2025
CompletionEst.
Oct 31, 2025
Last update
Jun 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06466668
Responsible party
Sponsor
First posted
Jun 20, 2024
Start date
Apr 29, 2024
Primary completion
Oct 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Jun 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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