Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06466668
Other study ID # B3002024000055
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 29, 2024
Est. completion date October 31, 2025

Study information

Verified date March 2024
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 120
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: - Known chronic medical conditions - Smoking - Bad self-reported health condition - Diagnosed chronic diseases

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Sleep study
All subjects will undergo a polysomnography at home
stress-related biomarkers and microbiome composition will be assessed using saliva samples
stress and stress-related inflammatory biomarkers will be tested using saliva sample
Audiological tests
Pure tone audiometry, Uncomfortable Loudness Levels, Distortion-Product Otoacoustic Emissions, tablet test for hyperacusis, tablet test for hearing screening

Locations

Country Name City State
Belgium Antwerp University Hospital (UZA) Edegem

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Antwerp Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Differences in the levels of stress-related biomarkers in saliva Quantification of hormones (e.g., cortisol) and cytokines (e.g., IL-8) by ELISA Single time point before sleep analysis
Secondary Differences in salivary microbiome composition Amplicon sequencing with the Illumina MiSeq Single time point before sleep analysis
See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT04513743 - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ N/A
Completed NCT03251274 - Bath Machine on Sleep Quality in Nursing Home N/A
Completed NCT04102345 - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG Early Phase 1
Completed NCT03725943 - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT04562181 - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index N/A
Completed NCT05576844 - Ai Youmian (Love Better Sleep) for People Living With HIV N/A
Completed NCT05102565 - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers N/A
Completed NCT04688099 - Synovial Fluid Sleep Study
Recruiting NCT04171245 - Prescribing Laughter for Sleep and Wellbeing in UAE University Students N/A
Completed NCT03758768 - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms N/A
Completed NCT03163498 - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed NCT04093271 - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep Phase 1
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4