Broadband Sound and Sleep
Study on the Use of Broadband Sound to Mitigate Sleep Disruption Due to Aircraft Noise
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2024
CompletedResults Posted
Study results publicly available
November 18, 2025
CompletedNovember 18, 2025
November 1, 2025
8 months
March 7, 2023
June 23, 2025
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time Spent in Slow Wave Sleep and Rapid Eye Movement (N3 + REM)
Combined time spent in sleep stages N3 and REM in minutes, as measured by polysomnography (PSG).
Days 2-7
Secondary Outcomes (4)
Cognition Efficiency
Days 2-7
Cognition Speed
Days 2-7
Cognition Accuracy
Days 2-7
Driving Simulator Standard Deviation of Lane Position
Days 2-7
Study Arms (6)
Pink Noise Only, 50 dBA (BN50)
EXPERIMENTALSubjects 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 Plus Pink Noise at 50 dBA (AN+BN50)
EXPERIMENTALSubjects 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.
Control (CTRL)
SHAM COMPARATORSubjects 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 Plus Pink Noise at 40 dBA (AN+BN40)
EXPERIMENTALSubjects 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 (AN)
EXPERIMENTALSubjects 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 Plus Earplugs (AN+EP)
EXPERIMENTALSubjects 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.
Interventions
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise and alerts during sleep from 2300-0700.
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
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.
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
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Civil Aerospace Medical Institutecollaborator
Study Sites (1)
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Related Publications (6)
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.
PMID: 25887528BACKGROUNDRiedy 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.
PMID: 33007706BACKGROUNDWatson 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.
PMID: 26039963BACKGROUNDBasner 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.
PMID: 29538344BACKGROUNDBasner 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.
PMID: 24183105BACKGROUNDBasner M, Smith MG, Cordoza M, Kayser MS, Carlin M, Ecker AJ, Gilad Y, Park-Chavar S, Rennie K, Schneller V, Walsh S, Shou H, Cao Q, Younes M, Aeschbach D, Jones CW. Efficacy of pink noise and earplugs for mitigating the effects of intermittent environmental noise exposure on sleep. Sleep. 2026 Feb 2:zsag001. doi: 10.1093/sleep/zsag001. Online ahead of print.
PMID: 41627391DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mathias Basner, MD, PhD, MScEpi
- Organization
- University of Pennsylvania Perelman School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Mathias Basner, MD, PhD, MSc
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Subjects, study personnel and those assessing outcomes will be unaware of order of the exposure conditions. Investigators will only learn about the condition after the start of the sleep period of participants.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 20, 2023
Study Start
October 31, 2023
Primary Completion
June 17, 2024
Study Completion
June 17, 2024
Last Updated
November 18, 2025
Results First Posted
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data files will be available one year after the project end date.
- Access Criteria
- People requesting the data will have to fulfill the access criteria set by the respective database.
Public project data files will be available via the National Transportation Library (NTL). Personally Identifiable Information (PII) will not be publicly available. Sensitive data that cannot be de-identified will be posted to secure government databases, such as posting of genetic sequence data in NIH's database of Genotypes and Phenotypes (dbGAP) (www.ncbi.nlm.nih.gov/gap/), where appropriate and in accordance with institutional review board (IRB) guidance and federal regulations.