Effect of Background Noise on Sleep Quality
Noise
Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality
1 other identifier
interventional
20
1 country
1
Brief Summary
Insufficient and low-quality sleep is a major public health problem that has been linked to motor vehicle crashes, industrial disasters, and medical and other occupational errors. Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity. The number of people using sleep-inducing drugs to increase or improve sleep is steadily increasing in the last few decades; however, the side effects of these therapies often outweigh the benefits. A few small trials and anecdotal findings suggest that continuous background (pink or white) noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce sleep onset latency. In an attempt to find new, alternative solutions to increase sleep quality in people suffering from insomnia, the investigators would like to test the effect of surrounding filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
May 25, 2018
CompletedMay 25, 2018
May 1, 2018
6 months
October 25, 2016
March 8, 2018
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Onset Latency (Mins)
time from lights out to the first epoch of stage 2 NREM sleep
1 night
Secondary Outcomes (1)
Subjective Sleep Quality (VAS)
1 night
Study Arms (2)
Background noise
ACTIVE COMPARATOROvernight sleep study with filtered white noise
Silence
NO INTERVENTIONOvernight sleep study with normal environmental noise
Interventions
Eligibility Criteria
You may qualify if:
- Age between 21 and 60
You may not qualify if:
- Any sleep disorder
- Use of hypnotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Wellman
- Organization
- Brigham and women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 26, 2016
Study Start
August 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
May 25, 2018
Results First Posted
May 25, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share