- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05774977
Broadband Sound and Sleep
Study on the Use of Broadband Sound to Mitigate Sleep Disruption Due to Aircraft Noise
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sierra Park-Chavar, BA
- Phone Number: 215-573-5855
- Email: sierrap@pennmedicine.upenn.edu
Study Contact Backup
- Name: Mathias Basner, MD, PhD, MSc
- Phone Number: 215-573-5866
- Email: basner@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania Perelman School of Medicine
-
Contact:
- Mathias Basner, MD, PhD
- Phone Number: 215-573-5866
- Email: basner@pennmedicine.edu
-
Principal Investigator:
- Mathias Basner, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult subjects between 21-50 years old
- Free of psychological/psychiatric conditions that preclude participation.
- BMI between 18.5 and 35.
- Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.
- Self-reported sleep duration of 6-8.5 h per night (verified by ambulatory sleep monitoring with wrist actigraphy and daily logs).
- Ability to read/write English.
- Fully vaccinated for or recovered from coronavirus (COVID-19).
Exclusion Criteria:
- Subjects habitually use broadband noise (e.g. white noise machines) to promote sleep at home.
- Hearing loss greater than 25 dB in any frequency band up to 8 kilohertz (kHz).
- History of neurological, psychiatric, or other medical condition that excludes participation.
- Current mania or psychosis.
- Current depression as determined by the Beck Depression Inventory with a score of 17 or greater (Beck, 1996).
- Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
- Excessive alcohol intake (above 21 drinks per week) or binge alcohol consumption (5 or more drinks per day).
- Excessive caffeine consumption (above 650mg/day combining all caffeinated drinks regularly absorbed during the day).
- Current smoker/tobacco user, or using nicotine replacement therapy. Those that have been nicotine-free for 30 days will be included.
- Body Mass Index at or below 18.5 or at or above 35.
- Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness based on history, physical exam, blood and urine chemistries, and complete blood count (CBC).
- Individuals who self-report a history of recurrent seizures or epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
- Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation.
- Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, cardiac arrhythmia, or patients requiring oxygen therapy (as determined by self-report).
- Currently working night, swing, split or rotating shift.
- Current use or use of within the past month of a prescription or over-the-counter sleep medication or stimulant; use of psychoactive medication (based on self-report and review with a study clinician).
- Pregnant or currently breast feeding.
- Prior history or diagnosis of any sleep disorder including Obstructive Sleep Apnea (OSA) (AHI at or above 15 events/hour) from ambulatory or in lab polysomnography; Restless legs syndrome or periodic limb movement disorder; Insomnia; Parasomnia; High Risk of OSA based on Stop-Bang Questionnaire (yes on at least 4 of 8 questions); High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire; High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher).
- Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver.
- Planned travel across more than one time zone one month prior to and/or during the anticipated period of the study.
- Intentional naps during the week.
- Positive COVID-19 test at prescreening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: A B C D E F
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 |
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Control night (CTRL) without noise exposure and without earplugs.
|
Experimental: Group 2: B D A F C E
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 |
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Control night (CTRL) without noise exposure and without earplugs.
|
Experimental: Group 3: C A E B F D
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 |
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Control night (CTRL) without noise exposure and without earplugs.
|
Experimental: Group 4: D F B E A C
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 |
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Control night (CTRL) without noise exposure and without earplugs.
|
Experimental: Group 5: E C F A D B
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 |
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Control night (CTRL) without noise exposure and without earplugs.
|
Experimental: Group 6: F E D C B A
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 |
The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
Control night (CTRL) without noise exposure and without earplugs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Spent in Sleep Stages N3 & Rapid Eye Movement (REM)
Time Frame: Days 2-7
|
Time spent in sleep stages N3 and REM
|
Days 2-7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognition Test Battery Performance
Time Frame: Days 1-7
|
Accuracy, speed and efficiency across cognitive domains using a test battery containing 10 cognitive tasks
|
Days 1-7
|
Driving Simulator Performance
Time Frame: Days 1-7
|
Standard deviation in lane drift and speed in a computerized driving simulation
|
Days 1-7
|
Hearing Test Threshold Shift
Time Frame: Days 1-7
|
Hearing test threshold shifts in dB at 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 6,000 Hz, and 8,000 Hz
|
Days 1-7
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mathias Basner, MD, PhD, MSc, University of Pennsylvania
Publications and helpful links
General Publications
- Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716.
- Huang HW, Zheng BL, Jiang L, Lin ZT, Zhang GB, Shen L, Xi XM. Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation? Crit Care. 2015 Mar 19;19(1):124. doi: 10.1186/s13054-015-0842-8.
- Riedy SM, Smith MG, Rocha S, Basner M. Noise as a sleep aid: A systematic review. Sleep Med Rev. 2021 Feb;55:101385. doi: 10.1016/j.smrv.2020.101385. Epub 2020 Sep 9.
- Basner M, McGuire S. WHO Environmental Noise Guidelines for the European Region: A Systematic Review on Environmental Noise and Effects on Sleep. Int J Environ Res Public Health. 2018 Mar 14;15(3):519. doi: 10.3390/ijerph15030519.
- Basner M, Babisch W, Davis A, Brink M, Clark C, Janssen S, Stansfeld S. Auditory and non-auditory effects of noise on health. Lancet. 2014 Apr 12;383(9925):1325-1332. doi: 10.1016/S0140-6736(13)61613-X. Epub 2013 Oct 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 852479
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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