NCT06466668

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

June 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

May 13, 2024

Last Update Submit

June 13, 2024

Conditions

Noise ExposureSleepHyperacusis

Outcome Measures

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.

    Single time point (before December 31 2025)

Secondary Outcomes (2)

  • Differences in the levels of stress-related biomarkers in saliva

    Single time point before sleep analysis

  • Differences in salivary microbiome composition

    Single time point before sleep analysis

Study Arms (2)

Hyperacusis

participants with hyperacusis (or an increased sensitivity to sound)

Diagnostic Test: Sleep studyDiagnostic Test: stress-related biomarkers and microbiome composition will be assessed using saliva samplesDiagnostic Test: Audiological tests

No hyperacusis

participants without hyperacusis (or an increased sensitivity to sound)

Diagnostic Test: Sleep studyDiagnostic Test: stress-related biomarkers and microbiome composition will be assessed using saliva samplesDiagnostic Test: Audiological tests

Interventions

Sleep studyDIAGNOSTIC_TEST

All subjects will undergo a polysomnography at home

HyperacusisNo hyperacusis
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

HyperacusisNo hyperacusis
Audiological testsDIAGNOSTIC_TEST

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

HyperacusisNo hyperacusis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital (UZA)

Edegem, 2650, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

MeSH Terms

Conditions

Hyperacusis

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

June 20, 2024

Study Start

April 29, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

June 20, 2024

Record last verified: 2024-03

Locations

BE(1)