Federal Aviation Administration (FAA) National Sleep Study (NCT05035940) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Federal Aviation Administration (FAA) National Sleep Study
United States401 participantsStarted 2021-09-07
Plain-language summary
This observational study will examine the relationship between aircraft noise exposure in the bedroom and objectively assessed sleep disturbance. Surveys will be mailed to randomly selected households around selected airports to recruit individuals for a 5 night in-home sleep study. Eligible survey respondents interested in participating in the sleep study will record nighttime indoor sounds using a portable audio recorder and wear a small device that collects heart rate and movement data for 5 consecutive nights. They will also complete brief morning questionnaires about their previous night's sleep and their sleep quality and a participant characteristics questionnaire. Collected data will be used to create an exposure-response model between aircraft noise exposure and sleep disturbance.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must currently live in a residence exposed to relevant levels of nocturnal aircraft traffic and have received a recruitment survey in the mail.
* Only one subject per household will be eligible, selected pseudo-randomly as the person in the household who most recently celebrated a birthday.
* In order to be eligible to participate in the in-home study, participants must have completed and returned the recruitment postal survey that was sent to their residence.
Exclusion Criteria:
Survey respondents interested in participating in the in-home sleep study are ineligible to participate if they:
* are less than 21 years of age;
* have a Body Mass Index (BMI) greater than 35 kg/m2 or less than 17 kg/m2;
* have been diagnosed with a sleep disorder, including obstructive or central sleep apnea, narcolepsy, restless legs syndrome, or periodic limb movement syndrome;
* frequently (3 or more times per week) use prescription or over the counter medication to aid sleep;
* have a hearing impairment;
* have a cardiac arrhythmia;
* work night shifts (defined as working for at least 4 hours between 00:00 to 06:00);
* have dependents that frequently require care during the night;
* are pregnant;
* previously participated in one of the pilot studies performed at Philadelphia airport or Atlanta airport; or
* habitually use earplugs or play back sounds in the bedroom that could mask aircraft noise.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Noise-induced awakening
Timeframe: First 45 seconds of each aircraft noise event