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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sleep; Hyperacusis; Noise Exposure
• Intervention / Treatment: Diagnostic test: Sleep study; Diagnostic test: stress-related biomarkers and microbiome composition will be assessed using saliva samples; Diagnostic test: Audiological tests

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Antwerp University Hospital (UZA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyperacusis; participants with hyperacusis (or an increased sensitivity to sound)	Diagnostic test: Sleep study; All subjects will undergo a polysomnography at home; Diagnostic test: stress-related biomarkers and microbiome composition will be assessed using saliva samples; stress and stress-related inflammatory biomarkers will be tested using saliva sample; Diagnostic test: Audiological tests; Pure tone audiometry, Uncomfortable Loudness Levels, Distortion-Product Otoacoustic Emissions, tablet test for hyperacusis, tablet test for hearing screening
No hyperacusis; participants without hyperacusis (or an increased sensitivity to sound)	Diagnostic test: Sleep study; All subjects will undergo a polysomnography at home; Diagnostic test: stress-related biomarkers and microbiome composition will be assessed using saliva samples; stress and stress-related inflammatory biomarkers will be tested using saliva sample; Diagnostic test: Audiological tests; Pure tone audiometry, Uncomfortable Loudness Levels, Distortion-Product Otoacoustic Emissions, tablet test for hyperacusis, tablet test for hearing screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Differences in salivary microbiome composition	Amplicon sequencing with the Illumina MiSeq	Single time point before sleep analysis

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hyperacusis
• Other Study ID Numbers: B3002024000055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No