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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Sound insulation of bedrooms is expensive and typically only granted to residents living close to the airport. We plan to investigate the effects of various aviation noises on sleep under controlled laboratory conditions and to investigate whether some of the sleep disturbing effects can be mitigated by introducing broadband noise into the bedroom or by wearing earplugs.

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 data supports the effectiveness of the treatment Broadband Sound for sleep disturbance due to noise exposure?

Research shows that certain ambient sounds can reduce awakenings during sleep, suggesting that sound-based treatments like Broadband Sound might help improve sleep quality by masking disruptive noises. ^{1 2 3 4 5}

Is noise-cancelling treatment safe for humans?

Research on noise exposure, including aircraft and wind turbine noise, suggests that noise can disrupt sleep but does not indicate any direct harm to human health from noise-cancelling methods like Broadband Sound. These methods are generally considered safe for humans. ^{4 6 7 8 9}

How does this treatment for sleep disturbance due to noise exposure differ from other treatments?

This treatment is unique because it uses a closed-loop system that adjusts the volume of pink noise based on brain activity, helping to reduce the time it takes to fall asleep and reach deep sleep. Unlike other treatments, it directly interacts with the brain's transition from wakefulness to sleep, making it a novel approach to managing sleep disturbances caused by noise. ^{1 10 11 12 13}

Research Team

Mathias Basner, MD, PhD, MSc

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Group 6: F E D C B A Experimental Treatment 6 Interventions

Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F. After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: F E D C B A

Group II: Group 5: E C F A D B Experimental Treatment 6 Interventions

Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F. After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: E C F A D B

Group III: Group 4: D F B E A C Experimental Treatment 6 Interventions

Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F. After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: D F B E A C

Group IV: Group 3: C A E B F D Experimental Treatment 6 Interventions

Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F. After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: C A E B F D

Group V: Group 2: B D A F C E Experimental Treatment 6 Interventions

Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F. After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: B D A F C E

Group VI: Group 1: A B C D E F Experimental Treatment 6 Interventions

Subjects will be exposed to six different conditions during a sleep period from 2300-0700. All subjects will experience all six conditions in a randomized and balanced fashion. Conditions #1-6 will be randomly assigned to letters A-F. After an adaptation night with no interventions on Night 1, subjects will receive the following exposure sequence on Nights 2-7: A B C D E F

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of two types of ambient sound during sleep. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Effect of noise tolerance on non-restorative sleep: a population-based study in Hong Kong. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The influence of hearing impairment on sleep quality among workers exposed to harmful noise. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Extra-auditory effects of noise in laboratory animals: the relationship between noise and sleep. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility, efficacy, and functional relevance of automated auditory closed-loop suppression of slow-wave sleep in humans. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Aircraft Noise on Sleep: Federal Aviation Administration National Sleep Study Protocol. [2023]

7. India pubmed.ncbi.nlm.nih.gov

Critical appraisal of methods for the assessment of noise effects on sleep. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Sleep actigraphy time-synchronized with wind turbine output. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of Wind Turbine Noise on Self-Reported and Objective Measures of Sleep. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Insomnia Characterization: From Hypnogram to Graph Spectral Theory. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Closed-loop Electroencephalogram-based modulated audio to fall and deepen sleep faster. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Self-applied ear-EEG for sleep monitoring at home. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Nightcap: laboratory and home-based evaluation of a portable sleep monitor. [2019]