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Noise-Cancelling Methods for Sleep Disturbance Due to Noise Exposure

N/A
Recruiting
Led By Mathias Basner, MD, PhD, MSc
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 2-7
Awards & highlights

Study Summary

This trial will study how airport noise can affect sleep and if noise-cancelling methods like earplugs or broadband noise can help.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There are minimal side effects expected in this trial as it involves exposure to different types of sounds during sleep rather than medication intake. However, participants might experience changes in their sleeping patterns or slight discomfort due to wearing earplugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 2-7
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 2-7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time Spent in Sleep Stages N3 & Rapid Eye Movement (REM)
Secondary outcome measures
Cognition Test Battery Performance
Driving Simulator Performance
Hearing Test Threshold Shift

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group 6: F E D C B AExperimental Treatment6 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 BExperimental Treatment6 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 CExperimental Treatment6 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 DExperimental Treatment6 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 EExperimental Treatment6 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 FExperimental Treatment6 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

Find a Location

Who is running the clinical trial?

Civil Aerospace Medical InstituteFED
3 Previous Clinical Trials
313 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,259 Total Patients Enrolled
5 Trials studying Noise Exposure
482 Patients Enrolled for Noise Exposure
Mathias Basner, MD, PhD, MScPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patients in this trial?

"Indeed, clinicaltrials.gov has made clear that this medical trial is looking for volunteers as of October 2nd 2023. The research proposal first appeared on November 13th 2023."

Answered by AI

Are participants of this trial required to be over a certain age?

"In order to be eligible for this medical trial, applicants must fall between 21 and 50 years old. Alternatively, there are two other clinical trials: one for minors and the other designed specifically for those over 65."

Answered by AI

How many individuals are partaking in this clinical investigation?

"Affirmative. Information accessible on clinicaltrials.gov confirms that this investigation, which was first uploaded on November 13th 2023, is actively recruiting with an aim to enrol 28 individuals from a single location."

Answered by AI

Can I be included in the research process?

"This clinical trial is accepting 28 individuals aged 21 to 50 with a history of noise exposure. To qualify, one must possess the following attributes: being within the adult age range of 21-50 years old; no having any psychological conditions that would contravene participation; a body mass index between 18.5 and 35.; possessing an established sleep schedule capable of maintenance throughout the duration of study, sleeping 6-8.5 hours per night (verified by both actigraphy monitoring and log keeping); reading/writing proficiency in English language; fully vaccinated or disease recovery from coronavirus (COVID-19)."

Answered by AI
Recent research and studies
SleepJournal
Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society
Watson, Nathaniel F., M. Safwan Badr, Gregory Belenky, Donald L. Bliwise, Orfeu M. Buxton, Daniel Buysse, David F. Dinges, et al.. 2015. “Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society”. Sleep. Oxford University Press (OUP). doi:10.5665/sleep.4716.
clinicaltrials.govStudy
Broadband Sound and Sleep
2023. "Broadband Sound and Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05774977.
~8 spots leftby Jun 2024
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