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.
