Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2016-08-31
2017-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Background noise
Overnight sleep study with filtered white noise
NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
Silence
Overnight sleep study with normal environmental noise
No interventions assigned to this group
Interventions
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NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of hypnotics
21 Years
60 Years
ALL
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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David Andrew Wellman
MD, PhD
Locations
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Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2016P000982
Identifier Type: -
Identifier Source: org_study_id
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