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OpenTrials
Completed

NCT Number: NCT05774977

Broadband Sound and Sleep

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.

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Cognition Efficiency

    Time frame: Days 2-7

    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).

  2. Cognition Speed

    Time frame: Days 2-7

    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).

  3. Cognition Accuracy

    Time frame: Days 2-7

    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).

  4. Driving Simulator Standard Deviation of Lane Position

    Time frame: Days 2-7

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Civil Aerospace Medical Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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