Federal Aviation Administration (FAA) National Sleep Study

NCT05035940 | Active Not Recruiting

• 1 other identifier: 833863
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

Noise Exposure

Keywords

Aircraft noise; Sleep disturbance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent highly sleep disturbed

  1 year

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Harris Miller Miller & Hanson Inc.: collaborator
• Westat: collaborator
• Federal Aviation Administration Office of Environment and Energy: collaborator

Study Sites (1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 32092522 BACKGROUND

• 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.

  PMID: 31805869 BACKGROUND

• 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.

  PMID: 31480420 BACKGROUND

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mathias Basner, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 5, 2021
• Study Start: September 7, 2021
• Primary Completion: October 31, 2023
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-04

Locations

US (1)