Clinical trial NCT05035940: Federal Aviation Administration (FAA) National Sleep Study
Official title: FAA National Sleep Study on the Effects of Aircraft Noise on Sleep
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Noise Exposure
Keywords: Aircraft noise
Sleep disturbance
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Federal Aviation Administration Office of Environment and Energy
name: Harris Miller Miller & Hanson Inc.
name: Westat
First posted: 2021-09-05
Enrollment: 401
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is adult residents of U.S. households who are exposed to relevant levels of nighttime air traffic (both in terms of number and sound pressure level of events) in communities in proximity to an airport meeting the eligibility criteria for this study.

Brief 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.

Detailed description: Individuals who complete the recruitment survey, indicate their interest in participating in the study, and meet the eligibility criteria, will be enrolled in the 5-night in-home sleep study to collect noise and physiological (heart rate, body movements) measurements, and answer questionnaires about experiences during the previous night and a characteristics questionnaire that collects additional information relevant for sleep. After confirmation of eligibility and informed consent, subjects will be sent equipment by mail to measure body movements and ECG signals as well as sounds in the bedroom. Awakenings will be inferred from ECG and movement data using a previously validated algorithm, and analyzed relative to measured noise levels in the bedroom. The study nights will take place during the week, Monday night/Tuesday morning through Friday night/Saturday morning. Upon completion of the 5 nights, the questionnaires and equipment will be returned to the study team by mail. Survey mailing distribution, subject recruitment, and data collection for the in-home sleep study is expected to last 2 years, but may last up to 3 years.

The study population is adult residents of U.S. households who are exposed to relevant levels of nighttime air traffic (both in terms of number and sound pressure level of events) in communities in proximity to 77 airports that met the eligibility criteria for this study. Only areas with expected aircraft noise exposure levels of ≥40 decibels (dB) Lnight (average aircraft noise level during the nighttime period) outside were considered for the sample frame. To maximize the likelihood that there will be a range of indoor noise levels in the sample frame, the investigators will use probability sampling stratified on outdoor aircraft noise contour levels. For each of the selected 77 airports, noise exposure contour strata, were determined using the FAA's Aviation Environmental Design Tool and 2018 traffic data. These noise contours are based on Lnight and include the 40, 45, 50, and 55 dB contour to allow for stratified sampling from the following areas: 40\<45, 45\<50, 50\<55, ≥55 dB. From each noise stratum, 100 subjects will be recruited into the in-home field study. Mailing addresses for the recruitment survey will be selected randomly from all households across the 77 airports within each of the 4 noise strata.

The primary study outcome is aircraft noise-induced awakening probability depending on the maximum sound pressure level of single aircraft events. Analyses will be weighted to better reflect the sampling universe, but unweighted analyses will also be performed. Secondary outcomes include, but are not limited to, self-reported sleep disturbance depending on noise metrics referring to longer time periods (i.e., last night or past year).

Eligibility criteria: 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.

Primary outcomes:
measure: Noise-induced awakening
timeFrame: First 45 seconds of each aircraft noise event
Secondary outcomes:
measure: Percent highly sleep disturbed
timeFrame: 1 year
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
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith MG, Rocha S, Witte M, Basner M. On the feasibility of measuring physiologic and self-reported sleep disturbance by aircraft noise on a national scale: A pilot study around Atlanta airport. Sci Total Environ. 2020 May 20;718:137368. doi: 10.1016/j.scitotenv.2020.137368. Epub 2020 Feb 17.
citation: Smith MG, Witte M, Rocha S, Basner M. Effectiveness of incentives and follow-up on increasing survey response rates and participation in field studies. BMC Med Res Methodol. 2019 Dec 5;19(1):230. doi: 10.1186/s12874-019-0868-8.
citation: Basner M, Witte M, McGuire S. Aircraft Noise Effects on Sleep-Results of a Pilot Study Near Philadelphia International Airport. Int J Environ Res Public Health. 2019 Aug 31;16(17):3178. doi: 10.3390/ijerph16173178.