Study on the Use of Broadband Sound to Mitigate Sleep Disruption Due to Aircraft Noise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Time Spent in Slow Wave Sleep and Rapid Eye Movement (N3 + REM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects between 21-50 years old
- •Free of psychological/psychiatric conditions that preclude participation.
- •BMI between 18.5 and
- •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).
排除标准
- •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
- •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.
结局指标
主要结局
Time Spent in Slow Wave Sleep and Rapid Eye Movement (N3 + REM)
时间窗: Days 2-7
Combined time spent in sleep stages N3 and REM in minutes, as measured by polysomnography (PSG).
次要结局
- Cognition Efficiency(Days 2-7)
- Driving Simulator Standard Deviation of Lane Position(Days 2-7)
- Cognition Speed(Days 2-7)
- Cognition Accuracy(Days 2-7)