Broadband Sound and Sleep

University of Pennsylvania

Status: Completed

Conditions: Noise Exposure

Treatments: Other: Aviation Noise Only (AN); Other: Aviation Noise With Earplugs (AN+EP); Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40); Other: Pink noise only, 50 dBA (BN50); Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05774977

852479

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: 27 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

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27 participants in 6 patient groups

Pink Noise Only, 50 dBA (BN50)

Experimental group

Description:

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Pink Noise at 50 dBA (BN50) condition once between nights 2 to 7. The Pink Noise at 50 dBA (BN50) night consisted of exposure to continuous pink broadband noise throughout the sleep period at a level of 50 A-weighted decibels (dBA). For the purposes of blinding, this was Condition A.

Treatment:

Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40)

Other: Pink noise only, 50 dBA (BN50)

Other: Aviation Noise With Earplugs (AN+EP)

Other: Aviation Noise Only (AN)

Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50)

Experimental group

Description:

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise + Pink Noise at 50 dBA (AN+BN50) condition once between nights 2-7. The Aviation Noise plus Pink Noise, 50 dBA (AN+BN50) night consisted of aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA (BN50). The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. For the purposes of blinding, this was Condition B.

Treatment:

Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40)

Other: Pink noise only, 50 dBA (BN50)

Other: Aviation Noise With Earplugs (AN+EP)

Other: Aviation Noise Only (AN)

Control (CTRL)

Sham Comparator group

Description:

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Control (CTRL) condition once between nights 2 to 7. The Control (CTRL) night had no interventions. There was no background broadband noise nor aviation noise, and subjects did not wear earplugs. For the purposes of blinding, this was Condition C.

Treatment:

Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40)

Other: Pink noise only, 50 dBA (BN50)

Other: Aviation Noise With Earplugs (AN+EP)

Other: Aviation Noise Only (AN)

Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40)

Experimental group

Description:

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise plus Pink Noise at 40 dBA (AN+BN40) condition once between nights 2 to 7. The Aviation Noise plus Pink Noise at 40 dBA (AN + BN40) night consisted of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 A-weighted decibels (dBA). The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. For the purposes of blinding, this was Condition D.

Treatment:

Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40)

Other: Pink noise only, 50 dBA (BN50)

Other: Aviation Noise With Earplugs (AN+EP)

Other: Aviation Noise Only (AN)

Aviation Noise (AN)

Experimental group

Description:

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise (AN) condition once between nights 2 to 7. The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. There was no broadband noise exposure overnight. For the purposes of blinding, this was Condition E.

Treatment:

Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40)

Other: Pink noise only, 50 dBA (BN50)

Other: Aviation Noise With Earplugs (AN+EP)

Other: Aviation Noise Only (AN)

Aviation Noise Plus Earplugs (AN+EP)

Experimental group

Description:

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise plus Earplugs (AN+EP) condition once between nights 2 to 7. The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. There was no broadband noise exposure. For the purposes of blinding, this was Condition F.

Treatment:

Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40)

Other: Pink noise only, 50 dBA (BN50)

Other: Aviation Noise With Earplugs (AN+EP)

Other: Aviation Noise Only (AN)