Noise ExposureNSSNCT05035940
Federal Aviation Administration (FAA) National Sleep Study
An observational study of Noise Exposure, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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).
- Conditions
- Noise Exposure
- Keywords
- Aircraft noise, Sleep disturbance
- Medical subject headings
- Parasomnias
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 45 seconds of each aircraft noise event
Secondary outcomes (1)
Percent highly sleep disturbed
The recruitment survey contains a question: "Thinking about the last year 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start7 Sep 2021
- Primary completion31 Oct 2023
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Aviation Administration Office of Environment and Energy, Harris Miller Miller & Hanson Inc., Westat
- Responsible party
- Principal investigator, Mathias Basner, MD, PhD, University of Pennsylvania
- Investigators
- Mathias Basner, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035940
- Sponsor's protocol ID
- 833863
- Acronym
- NSS
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 32092522Smith 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.
PubMed 31805869Basner 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.
PubMed 31480420
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAA National Sleep Study on the Effects of Aircraft Noise on Sleep
- ClinicalTrials.gov ID
- NCT05035940
- Acronym / sponsor ID
- NSS / 833863
- Conditions
- Noise Exposure
- Keywords
- Aircraft noise, Sleep disturbance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 401 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Federal Aviation Administration Office of Environment and Energy, Harris Miller Miller & Hanson Inc., Westat
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Noise-induced awakening
Time frame: First 45 seconds of each aircraft noise event
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.
1 secondary outcome
Percent highly sleep disturbed
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 32092522Smith 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.
- Background: PubMed 31805869Smith 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.
- Background: PubMed 31480420Basner 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Basner, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise Exposure, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noise-induced awakening (time frame: First 45 seconds of each aircraft noise event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035940, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.