Noise ExposureNCT05774977

Broadband Sound and Sleep

A study testing Aviation Noise Only (AN), Pink noise only, 50 dBA (BN50) and Aviation Noise With Earplugs (AN+EP) in people with Noise Exposure, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Noise Exposure
What is being tested?: Aviation Noise Only (AN), Pink noise only, 50 dBA (BN50) and Aviation Noise With Earplugs (AN+EP)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2023to 17 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Show all 22Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Study on the Use of Broadband Sound to Mitigate Sleep Disruption Due to Aircraft Noise

Read the 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 6-8.5 hours per night as verified by six days of ambulatory actigraphy and daily logs.

Conditions: Noise Exposure
Being tested: Aviation Noise Only (AN), Pink noise only, 50 dBA (BN50), Aviation Noise With Earplugs (AN+EP), Aviation Noise With Pink Noise, 40 dBA (AN+BN40), Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
Keywords: Sleep, Cognitive Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aviation Noise Only (AN)Other
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)Other
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)Other
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)Other
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)Other
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.

Study groups in NCT05774977
Study group	Role	What they receive
Pink Noise Only, 50 dBA (BN50)	Experimental	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. Receives: Other: Aviation Noise Only (AN); Other: Pink noise only, 50 dBA (BN50); Other: Aviation Noise With Earplugs (AN+EP); Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40); Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50)	Experimental	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. Receives: Other: Aviation Noise Only (AN); Other: Pink noise only, 50 dBA (BN50); Other: Aviation Noise With Earplugs (AN+EP); Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40); Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
Control (CTRL)	Sham comparator	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. Receives: Other: Aviation Noise Only (AN); Other: Pink noise only, 50 dBA (BN50); Other: Aviation Noise With Earplugs (AN+EP); Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40); Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40)	Experimental	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. Receives: Other: Aviation Noise Only (AN); Other: Pink noise only, 50 dBA (BN50); Other: Aviation Noise With Earplugs (AN+EP); Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40); Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
Aviation Noise (AN)	Experimental	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. Receives: Other: Aviation Noise Only (AN); Other: Pink noise only, 50 dBA (BN50); Other: Aviation Noise With Earplugs (AN+EP); Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40); Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)
Aviation Noise Plus Earplugs (AN+EP)	Experimental	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. Receives: Other: Aviation Noise Only (AN); Other: Pink noise only, 50 dBA (BN50); Other: Aviation Noise With Earplugs (AN+EP); Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40); Other: Aviation Noise With Pink Noise, 50 dBA (AN+BN50)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Days 2-7

Secondary outcomes (4)

Cognition Efficiency
Efficiency scores from 10 brief cognitive tasks are generated from accuracy \& speed of reaction/responding, represented here by standardized effect sizes, where higher scores indicate better performance. Test scores were adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Accuracy and speed across cognitive domains were calculated by averaging z-scores across the 10 tests, then averaged to calculate an efficiency metric.
Scores between -0.2 and +0.2 suggest no effect on efficiency (0=population mean).
Between -0.2 and -0.5 suggests a small negative effect (i.e. slightly less efficient).
Between -0.5 and -0.8 suggests a moderate negative effect. Scores below -0.8 suggest a large negative effect. Between 0.2 and 0.5 suggests a small positive effect. Between 0.5 and 0.8 suggests a moderate positive effect. Scores above 0.8 suggest a large positive effect (i.e. significantly more efficient).
Measured: Days 2-7
Cognition Speed
A single variable representing response time across 10 Cognitive tasks that cover a range of cognitive domains with known cerebral representation. Test scores were adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Speed across cognitive domains was calculated by averaging z-scores across the 10 tests. Higher scores reflect faster speed.
Scores between -0.2 and +0.2 suggest no effect on speed (0=population mean). Between -0.2 and -0.5 suggests a small negative effect (i.e. slightly slower). Between -0.5 and -0.8 suggests a moderate negative effect. Scores below -0.8 suggest a large negative effect (i.e. significantly slower). Between 0.2 and 0.5 suggests a small positive effect (i.e. slightly faster). Between 0.5 and 0.8 suggests a moderate positive effect. Scores above 0.8 suggest a large positive effect (i.e. significantly faster).
Measured: Days 2-7
Cognition Accuracy
A single variable representing response time across 10 Cognitive tasks that cover a range of cognitive domains with known cerebral representation. Test scores were adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Accuracy across cognitive domains was calculated by averaging z-scores across the 10 tests. Higher scores reflect better accuracy.
Scores between -0.2 and +0.2 suggest no effect on accuracy (0=population mean). Between -0.2 and -0.5 suggests a small negative effect (i.e. slightly less accurate).
Between -0.5 and -0.8 suggests a moderate negative effect. Scores below -0.8 suggest a large negative effect (i.e. significantly less accurate).
Between 0.2 and 0.5 suggests a small positive effect (i.e. slightly more accurate).
Between 0.5 and 0.8 suggests a moderate positive effect. Scores above 0.8 suggest a large positive effect (i.e. significantly more accurate).
Measured: Days 2-7
Driving Simulator Standard Deviation of Lane Position
The standard deviation of lane position reflects the extent (in feet) to which participants "swerve" within the lane in a virtual driving simulator, often used to investigate the effects of impairment on driving performance, where higher values represent worse performance.
Measured: Days 2-7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202317 Jun 2024

First posted20 Mar 2023
Study start31 Oct 2023
Primary completion17 Jun 2024
Study completion17 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Noise ExposureStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: We will investigate participants in 7 groups of 4 subjects each. For six nights following an adaptation night, a different noise condition occurred each night. Each participant of a group was exposed to the same condition in each study night. In this randomization paradigm, each condition will appear in each position exactly once, and will be preceded by each other condition exactly once.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05774977
Sponsor's protocol ID: 852479
Status last verified: Nov 2025
First submitted: 7 Mar 2023
Last updated: 18 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 25887528
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.
PubMed 33007706
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.
PubMed 26039963
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.
PubMed 29538344
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.
PubMed 24183105
Basner 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. The efficacy of pink noise and earplugs for mitigating sleep disruption induced by different environmental noise sources. Sleep Health. 2026 Aug;12(4):702-706. doi: 10.1016/j.sleh.2026.03.009. Epub 2026 May 13.
PubMed 42120238
Basner 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 May 12;49(5):zsag001. doi: 10.1093/sleep/zsag001.
PubMed 41627391

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
Active, not recruitingObservational study
Federal Aviation Administration (FAA) National Sleep Study
Noise Exposure

All Noise Exposure trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Use of Broadband Sound to Mitigate Sleep Disruption Due to Aircraft Noise
ClinicalTrials.gov ID: NCT05774977
Acronym / sponsor ID: 852479
Conditions: Noise Exposure
Keywords: Sleep, Cognitive Performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Civil Aerospace Medical Institute
Study start: 31 Oct 2023 (actual)
Primary completion: 17 Jun 2024 (actual)
Study completion: 17 Jun 2024 (actual)
First posted: 20 Mar 2023 (actual)
Results: Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6
Model description: We will investigate participants in 7 groups of 4 subjects each. For six nights following an adaptation night, a different noise condition occurred each night. Each participant of a group was exposed to the same condition in each study night. In this randomization paradigm, each condition will appear in each position exactly once, and will be preceded by each other condition exactly once.

Arm	Type	Receives
Pink Noise Only, 50 dBA (BN50)	Experimental	Other: Aviation Noise Only (AN), Other: Pink noise only, 50 dBA (BN50), Other: Aviation Noise With Earplugs (AN+EP), Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40), Other: Aviation Noise With Pink Noise, 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 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)	Experimental	Other: Aviation Noise Only (AN), Other: Pink noise only, 50 dBA (BN50), Other: Aviation Noise With Earplugs (AN+EP), Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40), Other: Aviation Noise With Pink Noise, 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.
Control (CTRL)	Sham comparator	Other: Aviation Noise Only (AN), Other: Pink noise only, 50 dBA (BN50), Other: Aviation Noise With Earplugs (AN+EP), Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40), Other: Aviation Noise With Pink Noise, 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 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)	Experimental	Other: Aviation Noise Only (AN), Other: Pink noise only, 50 dBA (BN50), Other: Aviation Noise With Earplugs (AN+EP), Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40), Other: Aviation Noise With Pink Noise, 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 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)	Experimental	Other: Aviation Noise Only (AN), Other: Pink noise only, 50 dBA (BN50), Other: Aviation Noise With Earplugs (AN+EP), Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40), Other: Aviation Noise With Pink Noise, 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 (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)	Experimental	Other: Aviation Noise Only (AN), Other: Pink noise only, 50 dBA (BN50), Other: Aviation Noise With Earplugs (AN+EP), Other: Aviation Noise With Pink Noise, 40 dBA (AN+BN40), Other: Aviation Noise With Pink Noise, 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 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.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (22 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Aviation Noise (AN), Aviation Noise Plus Earplugs (AN+EP), Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40), Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50), Control (CTRL), Pink Noise Only, 50 dBA (BN50)
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).	Other	Aviation Noise (AN), Aviation Noise Plus Earplugs (AN+EP), Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40), Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50), Control (CTRL), Pink Noise Only, 50 dBA (BN50)
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.	Other	Aviation Noise (AN), Aviation Noise Plus Earplugs (AN+EP), Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40), Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50), Control (CTRL), Pink Noise Only, 50 dBA (BN50)
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.	Other	Aviation Noise (AN), Aviation Noise Plus Earplugs (AN+EP), Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40), Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50), Control (CTRL), Pink Noise Only, 50 dBA (BN50)
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.	Other	Aviation Noise (AN), Aviation Noise Plus Earplugs (AN+EP), Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40), Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50), Control (CTRL), Pink Noise Only, 50 dBA (BN50)

Primary outcome

Time Spent in Slow Wave Sleep and Rapid Eye Movement (N3 + REM)
Time frame: Days 2-7
Combined time spent in sleep stages N3 and REM in minutes, as measured by polysomnography (PSG).

4 secondary outcomes

Cognition Efficiency
Time frame: Days 2-7
Cognition Speed
Time frame: Days 2-7
Cognition Accuracy
Time frame: Days 2-7
Driving Simulator Standard Deviation of Lane Position
Time frame: Days 2-7

Results and safety

Results posted to the registry on 18 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Noise Condition	27	25

Primary outcome: Time Spent in Slow Wave Sleep and Rapid Eye Movement (N3 + REM)

Time frame: Days 2-7. Least squares mean (95% Confidence Interval). Unit: Minutes

Measure	Aviation Noise Only n = 25	Pink Noise Only (50 dBA) n = 25	Aviation Noise With Earplugs n = 21	Aviation Noise With Pink Noise, 40 dBA n = 24	Aviation Noise With Pink Noise, 50 dBA n = 24	Control n = 25
Value	188.5532184 (172.8271298 to 204.279307)	195.9798771 (180.1286092 to 211.831145)	209.51862074703 (193.2405983 to 225.7966432)	176.4599674 (160.6090035 to 192.3109313)	174.2895997 (158.4417133 to 190.1374861)	219.0943443 (203.4591503 to 234.7295384)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were monitored for adverse events over the course of their in-laboratory participation, starting with the adaptation night through the completion of the six overnight conditions, for a period of 7 nights.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: A B C D E F	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 2: B D A F C E	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 3: C A E B C D	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 4: D F B E A C	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Group 5: E C F B D A	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 6: F E D C B A	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 7: C D E A F B	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25887528Huang 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.
Background: PubMed 33007706Riedy 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.
Background: PubMed 26039963Watson 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.
Background: PubMed 29538344Basner 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.
Background: PubMed 24183105Basner 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.
Derived from this study: PubMed 42120238Basner 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. The efficacy of pink noise and earplugs for mitigating sleep disruption induced by different environmental noise sources. Sleep Health. 2026 Aug;12(4):702-706. doi: 10.1016/j.sleh.2026.03.009. Epub 2026 May 13.
Derived from this study: PubMed 41627391Basner 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 May 12;49(5):zsag001. doi: 10.1093/sleep/zsag001.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mathias Basner, MD, PhD, MSc principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Spent in Slow Wave Sleep and Rapid Eye Movement (N3 + REM) (time frame: Days 2-7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05774977, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.