Study Results
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View full resultsBasic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2023-10-31
2024-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Pink Noise Only, 50 dBA (BN50)
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.
Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
Pink noise only, 50 dBA (BN50)
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
Aviation Noise With Earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
Aviation Noise With Pink Noise, 40 dBA (AN+BN40)
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50)
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.
Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
Pink noise only, 50 dBA (BN50)
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
Aviation Noise With Earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
Aviation Noise With Pink Noise, 40 dBA (AN+BN40)
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Control (CTRL)
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.
Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
Pink noise only, 50 dBA (BN50)
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
Aviation Noise With Earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
Aviation Noise With Pink Noise, 40 dBA (AN+BN40)
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40)
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.
Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
Pink noise only, 50 dBA (BN50)
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
Aviation Noise With Earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
Aviation Noise With Pink Noise, 40 dBA (AN+BN40)
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Aviation Noise (AN)
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.
Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
Pink noise only, 50 dBA (BN50)
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
Aviation Noise With Earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
Aviation Noise With Pink Noise, 40 dBA (AN+BN40)
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Aviation Noise Plus Earplugs (AN+EP)
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.
Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
Pink noise only, 50 dBA (BN50)
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
Aviation Noise With Earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
Aviation Noise With Pink Noise, 40 dBA (AN+BN40)
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Interventions
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Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
Pink noise only, 50 dBA (BN50)
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
Aviation Noise With Earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
Aviation Noise With Pink Noise, 40 dBA (AN+BN40)
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
50 Years
ALL
Yes
Sponsors
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Civil Aerospace Medical Institute
FED
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Mathias Basner, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Countries
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References
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Huang HW, Zheng BL, Jiang L, Lin ZT, Zhang GB, Shen L, Xi XM. Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation? Crit Care. 2015 Mar 19;19(1):124. doi: 10.1186/s13054-015-0842-8.
Riedy SM, Smith MG, Rocha S, Basner M. Noise as a sleep aid: A systematic review. Sleep Med Rev. 2021 Feb;55:101385. doi: 10.1016/j.smrv.2020.101385. Epub 2020 Sep 9.
Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716.
Basner M, McGuire S. WHO Environmental Noise Guidelines for the European Region: A Systematic Review on Environmental Noise and Effects on Sleep. Int J Environ Res Public Health. 2018 Mar 14;15(3):519. doi: 10.3390/ijerph15030519.
Basner M, Babisch W, Davis A, Brink M, Clark C, Janssen S, Stansfeld S. Auditory and non-auditory effects of noise on health. Lancet. 2014 Apr 12;383(9925):1325-1332. doi: 10.1016/S0140-6736(13)61613-X. Epub 2013 Oct 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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852479
Identifier Type: -
Identifier Source: org_study_id
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