Noise-Cancelling Methods for Sleep Disturbance Due to Noise Exposure

Overseen By Mathias Basner, MD, PhD, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Sleep medications, Stimulants

Disqualifiers: Psychiatric conditions, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 7 nights

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to reduce sleep disturbances caused by noise, such as airplane sounds. It tests whether steady background noise (like broadband sound) or earplugs can improve sleep quality when exposed to these sounds. Participants will experience different noise conditions during sleep sessions to determine the most effective solution. The trial seeks individuals who do not currently use white noise at night and maintain a regular sleep pattern of about 6-8.5 hours per night. As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance sleep quality for many people.

Will I have to stop taking my current medications?

The trial requires that you do not use any prescription or over-the-counter sleep medications, stimulants, or psychoactive medications for at least a month before participating.

What prior data suggests that these noise-cancelling methods are safe for sleep disturbance mitigation?

Research shows that using a steady sound in the bedroom can reduce the impact of disruptive noises, such as airplane sounds, that disturb sleep. However, specific information on the safety of using steady sound in this manner is not yet available.

Loud and constant noise can cause health problems like stress and hearing loss, but steady sound differs. It is a gentle, continuous noise that may help mask other disruptive sounds, making sleep more restful.

Since this trial studies how steady sound affects sleep, much is still unknown about any side effects from its use. However, testing in this trial suggests some confidence in its safety. Participants are helping to gather more information about how well this approach improves sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores noise-cancelling methods to improve sleep quality, which could offer a non-invasive alternative to current treatments like sleeping pills and earplugs. Unlike these traditional options, which can have side effects or provide limited relief, broadband sound aims to create a sound environment that actively reduces the perception of disruptive noises. This method could lead to more natural and restful sleep without medication, and researchers hope to uncover how effective it can be across different noise conditions.

What evidence suggests that this trial's methods could be effective for sleep disturbance due to noise exposure?

Research shows that broadband sound, such as white noise, helps people fall asleep faster, reducing the time to drift off by 38% compared to regular background noise. It also enhances sleep efficiency, allowing for sounder sleep and fewer awakenings. This sound type is particularly beneficial in noisy environments, like hospitals, as it masks disruptive noises. In this trial, participants will experience various noise-cancelling conditions, including broadband sound, to evaluate its effectiveness in improving sleep quality. Overall, broadband sound reduces nighttime awakenings and enhances sleep quality. ^{6 7 8 9 10}

Who Is on the Research Team?

Mathias Basner, MD, PhD, MSc

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Adults aged 21-50 with a regular sleep schedule, normal BMI (18.5-35), and no major health issues can join this study on how different sounds affect sleep. Must be fluent in English, vaccinated or recovered from COVID-19, not pregnant or breastfeeding, without hearing loss, severe mental health conditions, substance abuse history, or use of certain medications.

Inclusion Criteria

BMI between 18.5 and 35

Ability to read/write English

Free of psychological/psychiatric conditions that preclude participation

Exclusion Criteria

I do not have any severe ongoing illnesses or major psychiatric conditions.

Body Mass Index at or below 18.5 or at or above 35

I have used sleep or stimulant medication in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation

Participants undergo an adaptation night with no interventions to acclimate to the study environment

1 night

1 visit (in-person)

Treatment

Participants are exposed to various sound conditions during sleep over 7 consecutive nights

7 nights

7 visits (in-person)

Follow-up

Participants are monitored for changes in hearing, cognitive performance, and driving simulation performance

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Broadband Sound

Trial Overview The trial tests the impact of various noises on sleep quality: aviation noise alone; combined with earplugs; mixed with white noise at two levels (40 dBA and 50 dBA); pink noise at 50 dBA; and a control night without added sound. Participants' bedrooms will simulate these conditions to see if broadband noise or earplugs help improve sleep disturbed by aviation noise.

How Is the Trial Designed?

Group I: Pink Noise Only, 50 dBA (BN50) Experimental Treatment 5 Interventions

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Pink Noise at 50 dBA (BN50) condition once between nights 2 to 7. The Pink Noise at 50 dBA (BN50) night consisted of exposure to continuous pink broadband noise throughout the sleep period at a level of 50 A-weighted decibels (dBA). For the purposes of blinding, this was Condition A.

Group II: Aviation Noise Plus Pink Noise at 50 dBA (AN+BN50) Experimental Treatment 5 Interventions

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise + Pink Noise at 50 dBA (AN+BN50) condition once between nights 2-7. The Aviation Noise plus Pink Noise, 50 dBA (AN+BN50) night consisted of aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA (BN50). The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. For the purposes of blinding, this was Condition B.

Group III: Aviation Noise Plus Pink Noise at 40 dBA (AN+BN40) Experimental Treatment 5 Interventions

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise plus Pink Noise at 40 dBA (AN+BN40) condition once between nights 2 to 7. The Aviation Noise plus Pink Noise at 40 dBA (AN + BN40) night consisted of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 A-weighted decibels (dBA). The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. For the purposes of blinding, this was Condition D.

Group IV: Aviation Noise Plus Earplugs (AN+EP) Experimental Treatment 5 Interventions

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise plus Earplugs (AN+EP) condition once between nights 2 to 7. The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. There was no broadband noise exposure. For the purposes of blinding, this was Condition F.

Group V: Aviation Noise (AN) Experimental Treatment 5 Interventions

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Aviation Noise (AN) condition once between nights 2 to 7. The aviation noise (AN) was a pre-programmed recording of 93 sounds including aviation-related noise (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying), ranging from 45 dB to 65 dB, played during sleep from 2300-0700. There was no broadband noise exposure overnight. For the purposes of blinding, this was Condition E.

Group VI: Control (CTRL) Placebo Group 5 Interventions

Subjects were exposed to six different conditions during a sleep opportunity period from 2300-0700. After an adaptation night with no interventions on night 1, subjects received the Control (CTRL) condition once between nights 2 to 7. The Control (CTRL) night had no interventions. There was no background broadband noise nor aviation noise, and subjects did not wear earplugs. For the purposes of blinding, this was Condition C.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Civil Aerospace Medical Institute

Collaborator

Trials

4

Recruited

340+

Published Research Related to This Trial

In a study involving 28 adults with disturbed sleep, both Sound A and Sound B were found to reduce the number of awakenings compared to baseline, indicating potential benefits for subjective sleep quality.

While Sound B showed some effects on objectively measured sleep, neither sound improved morning psychomotor performance, suggesting that while ambient sounds may help with sleep disturbances, they do not necessarily enhance daytime functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of two types of ambient sound during sleep. Montgomery-Downs, HE., Insana, SP., Miller, EA.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5742584/

Broadband Sound Administration Improves Sleep Onset ... Broadband sound significantly reduced sleep onset latency by 38% compared to normal environmental noise, reducing the time from lights out to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9272916/

Environmental Noise and Effects on Sleep: An Update to ... Awakenings, falling asleep, and sleep disturbance were the three outcomes included. Extracted data were used to derive exposure–response ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079220301283

Noise as a sleep aid: A systematic review We conducted a systematic review of all studies examining the relationships between continuous white noise or similar broadband noise and sleep (PROSPERO 2020: ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000175

Impact and efficacy of Sound Machine on Sleep in ... Collectively, these studies provide evidence of improved sleep efficiency with white noise use in hospitalized adults. Given the heterogeneity ...

5. sleepfoundation.org sleepfoundation.org/noise-and-sleep

How Noise Can Affect Your Sleep Satisfaction Noise can cause fragmented sleep, change sleep stages, increase hormones, and lead to sleepiness, irritability, and potentially long-term ...

6. ehp.niehs.nih.gov ehp.niehs.nih.gov/1307272

Environmental Noise Pollution in the United States Tens of millions of Americans suffer from a range of adverse health outcomes due to noise exposure, including heart disease and hearing loss.

7. apha.org apha.org/policy-and-advocacy/public-health-policy-briefs/policy-database/2022/01/07/noise-as-a-public-health-hazard

Noise as a Public Health Hazard Chronic noise, even at low levels, can cause annoyance, sleep disruption, and stress that contribute to cardiovascular disease, cerebrovascular disease, ...

8. osha.gov osha.gov/noise/health-effects

Occupational Noise Exposure - Health Effects Health Effects Exposure to high levels of noise can cause permanent hearing loss. Neither surgery nor a hearing aid can correct this type of hearing loss.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8204275/

The prevalence of occupational exposure to noise Evidence from mechanistic and human data suggests that occupational exposure to noise may cause cardiovascular disease. In this paper, we present a systematic ...

10. aap.org aap.org/en/patient-care/environmental-health/promoting-healthy-environments-for-children/noise/?srsltid=AfmBOoqnHPOLic0IX9TpWFyHKBRpcL43GSFa4SJsj3wuubyfAl6TtPr4

Noise Exposure Noise risk is based on both the level and the duration of noise. The louder the sound, the shorter the amount of time it takes for damage to ...