Federal Aviation Administration (FAA) National Sleep Study (NSS)

FAA National Sleep Study on the Effects of Aircraft Noise on Sleep

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Noise Exposure

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, we 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).

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Perelman School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noise-induced awakening	The probability of awakening (assessed with heart rate and body movements) depending on the maximum sound pressure level of an aircraft overflight (LAS,max measured inside the bedroom) during an aircraft noise event.	First 45 seconds of each aircraft noise event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent highly sleep disturbed	The recruitment survey contains a question: "Thinking about the last 12 months or so, when you are here at home, how much does noise from aircraft disturb your sleep?" Subjects choosing "very" or "extremely" on the 5-point answer scale will be considered highly sleep disturbed. The investigators will investigate how long-term aircraft noise exposure metrics are associated with being highly sleep disturbed.	Last 12 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Federal Aviation Administration Office of Environment and Energy; Harris Miller Miller & Hanson Inc.; Westat
• Investigators: Principal Investigator: Mathias Basner, MD, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Aircraft noise; Sleep disturbance
• Other Study ID Numbers: 833863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Together with the sponsor, the study team is in the process of defining which data will be made available to the public after the end of the study in accordance with the Federal Records Retention Schedule.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No