Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466668
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-20
First Post:
2024-05-13
Brief Title:
De Oorzaak Citizen Science Project on the Impact of Environmental Noise
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
De Oorzaak Impact of Environmental Noise on Sleep Quality and Stress and the Role of Auditive Sensitivity in This
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 nights 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 ie intolerance for daily sounds subsequently it will be assessed whether this sound sensitivity results in a difference in sleep quality and stress
Sound has a significant impact on both sleep quality and quality of life A calm quiet environment is essential for a good nights 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 ie intolerance for daily sounds subsequently it will be assessed whether this sound sensitivity results in a difference in sleep quality and stress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None