Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774977
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-03-07
Brief Title:
Broadband Sound and Sleep
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Study on the Use of Broadband Sound to Mitigate Sleep Disruption Due to Aircraft Noise
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Sound insulation of bedrooms is expensive and typically only granted to residents living close to the airport We plan to investigate the effects of various aviation noises on sleep under controlled laboratory conditions and to investigate whether some of the sleep disturbing effects can be mitigated by introducing broadband noise into the bedroom or by wearing earplugs
Detailed Description:
The Federal Aviation Administration is interested in investigating inexpensive yet effective methods to mitigate the adverse effects of aviation noise on sleep The sleep of up to 28 subjects will be monitored with polysomnography and actigraphy over 7 consecutive nights in groups of 4 exposed to various sound conditions aviation noise broadband noise aviation noise plus earplugs aviation noise plus broadband noise at various decibel dB levels Subjects will fill out surveys perform cognitive tasks and a hearing test before and after each sleep period The study will be performed in the Chronobiology Isolation Laboratory CIL in the Hospital of the University of Pennsylvania This newly constructed facility includes 4 acoustically isolated bedrooms and a high-fidelity sound system Eligible subjects are age 21-50 free of psychiatric conditions that preclude participation and maintain a self-reported regular sleep schedule of 6-85 hours per night as verified by six days of ambulatory actigraphy and daily logs
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