Clinical trial NCT05774977: Broadband Sound and Sleep
Official title: Study on the Use of Broadband Sound to Mitigate Sleep Disruption Due to Aircraft Noise
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Noise Exposure
Keywords: Sleep
Cognitive Performance
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Civil Aerospace Medical Institute
First posted: 2023-03-20
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We will investigate participants in 6 groups of 4 subjects each. Each participant of a group will be exposed to the same condition in each study night. In this randomization paradigm, each condition appears in each position exactly once, and is preceded by each other condition exactly once.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time Spent in Sleep Stages N3 & Rapid Eye Movement (REM)
timeFrame: Days 2-7
Secondary outcomes:
measure: Cognition Test Battery Performance
timeFrame: Days 1-7
measure: Driving Simulator Performance
timeFrame: Days 1-7
measure: Hearing Test Threshold Shift
timeFrame: Days 1-7
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mathias Basner, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.