Broadband Sound and Sleep

Noise Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774977
• Other study ID #: 852479
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: Sierra Park-Chavar, BA
• Phone: 215-573-5855
• Email: sierrap[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 broadband noise into the bedroom or by wearing earplugs.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Noise Exposure

Intervention

Other:
• Aviation Noise Only (AN)
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
• Pink noise, 50 dBA only (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 plus earplugs (AN+EP)
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
• Aviation noise plus white 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 plus white 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 Night (CTRL)
Control night (CTRL) without noise exposure and without earplugs.

Locations

Country	Name	City	State
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Civil Aerospace Medical Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Spent in Sleep Stages N3 & Rapid Eye Movement (REM)	Time spent in sleep stages N3 and REM	Days 2-7
Secondary	Cognition Test Battery Performance	Accuracy, speed and efficiency across cognitive domains using a test battery containing 10 cognitive tasks	Days 1-7
Secondary	Driving Simulator Performance	Standard deviation in lane drift and speed in a computerized driving simulation	Days 1-7
Secondary	Hearing Test Threshold Shift	Hearing test threshold shifts in dB at 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 6,000 Hz, and 8,000 Hz	Days 1-7