Broadband Sound and Sleep
Status
Active, not recruiting
Conditions
Noise Exposure
Treatments
Other: Pink noise, 50 dBA only (BN50)
Other: Aviation noise plus earplugs (AN+EP)
Other: Aviation noise plus white noise 40 dBA (AN+BN40)
Other: Aviation noise plus white noise 50 dBA (AN+BN50)
Other: Control Night (CTRL)
Other: Aviation Noise Only (AN)
Details and patient eligibility
About
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.
Full 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 6-8.5 hours per night as verified by six days of ambulatory actigraphy and daily logs.
Enrollment
24 patients
Sex
All
Ages
21 to 50 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Adult subjects between 21-50 years old
- Free of psychological/psychiatric conditions that preclude participation.
- BMI between 18.5 and 35.
- Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.
- Self-reported sleep duration of 6-8.5 h per night (verified by ambulatory sleep monitoring with wrist actigraphy and daily logs).
- Ability to read/write English.
- Fully vaccinated for or recovered from coronavirus (COVID-19).
Exclusion criteria
- Subjects habitually use broadband noise (e.g. white noise machines) to promote sleep at home.
- Hearing loss greater than 25 dB in any frequency band up to 8 kilohertz (kHz).
- History of neurological, psychiatric, or other medical condition that excludes participation.
- Current mania or psychosis.
- Current depression as determined by the Beck Depression Inventory with a score of 17 or greater (Beck, 1996).
- Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
- Excessive alcohol intake (above 21 drinks per week) or binge alcohol consumption (5 or more drinks per day).
- Excessive caffeine consumption (above 650mg/day combining all caffeinated drinks regularly absorbed during the day).
- Current smoker/tobacco user, or using nicotine replacement therapy. Those that have been nicotine-free for 30 days will be included.
- Body Mass Index at or below 18.5 or at or above 35.
- Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness based on history, physical exam, blood and urine chemistries, and complete blood count (CBC).
- Individuals who self-report a history of recurrent seizures or epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
- Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation.
- Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, cardiac arrhythmia, or patients requiring oxygen therapy (as determined by self-report).
- Currently working night, swing, split or rotating shift.
- Current use or use of within the past month of a prescription or over-the-counter sleep medication or stimulant; use of psychoactive medication (based on self-report and review with a study clinician).
- Pregnant or currently breast feeding.
- Prior history or diagnosis of any sleep disorder including Obstructive Sleep Apnea (OSA) (AHI at or above 15 events/hour) from ambulatory or in lab polysomnography; Restless legs syndrome or periodic limb movement disorder; Insomnia; Parasomnia; High Risk of OSA based on Stop-Bang Questionnaire (yes on at least 4 of 8 questions); High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire; High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher).
- Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver.
- Planned travel across more than one time zone one month prior to and/or during the anticipated period of the study.
- Intentional naps during the week.
- Positive COVID-19 test at prescreening.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Triple Blind
24 participants in 6 patient groups
Group 1: A B C D E F
Experimental group
Description:
Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F.
After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: A B C D E F
Treatment:
Other: Aviation Noise Only (AN)
Other: Control Night (CTRL)
Other: Aviation noise plus white noise 50 dBA (AN+BN50)
Other: Aviation noise plus white noise 40 dBA (AN+BN40)
Other: Aviation noise plus earplugs (AN+EP)
Other: Pink noise, 50 dBA only (BN50)
Group 2: B D A F C E
Experimental group
Description:
Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F.
After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: B D A F C E
Treatment:
Other: Aviation Noise Only (AN)
Other: Control Night (CTRL)
Other: Aviation noise plus white noise 50 dBA (AN+BN50)
Other: Aviation noise plus white noise 40 dBA (AN+BN40)
Other: Aviation noise plus earplugs (AN+EP)
Other: Pink noise, 50 dBA only (BN50)
Group 3: C A E B F D
Experimental group
Description:
Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F.
After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: C A E B F D
Treatment:
Other: Aviation Noise Only (AN)
Other: Control Night (CTRL)
Other: Aviation noise plus white noise 50 dBA (AN+BN50)
Other: Aviation noise plus white noise 40 dBA (AN+BN40)
Other: Aviation noise plus earplugs (AN+EP)
Other: Pink noise, 50 dBA only (BN50)
Group 4: D F B E A C
Experimental group
Description:
Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F.
After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: D F B E A C
Treatment:
Other: Aviation Noise Only (AN)
Other: Control Night (CTRL)
Other: Aviation noise plus white noise 50 dBA (AN+BN50)
Other: Aviation noise plus white noise 40 dBA (AN+BN40)
Other: Aviation noise plus earplugs (AN+EP)
Other: Pink noise, 50 dBA only (BN50)
Group 5: E C F A D B
Experimental group
Description:
Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F.
After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: E C F A D B
Treatment:
Other: Aviation Noise Only (AN)
Other: Control Night (CTRL)
Other: Aviation noise plus white noise 50 dBA (AN+BN50)
Other: Aviation noise plus white noise 40 dBA (AN+BN40)
Other: Aviation noise plus earplugs (AN+EP)
Other: Pink noise, 50 dBA only (BN50)
Group 6: F E D C B A
Experimental group
Description:
Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F.
After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: F E D C B A
Treatment:
Other: Aviation Noise Only (AN)
Other: Control Night (CTRL)
Other: Aviation noise plus white noise 50 dBA (AN+BN50)
Other: Aviation noise plus white noise 40 dBA (AN+BN40)
Other: Aviation noise plus earplugs (AN+EP)
Other: Pink noise, 50 dBA only (BN50)
Trial contacts and locations
1
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Central trial contact
Mathias Basner, MD, PhD, MSc; Sierra Park-Chavar, BA
Data sourced from clinicaltrials.gov
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