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Effect of Background Noise on Sleep Quality (Noise)

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ClinicalTrials.gov Identifier: NCT02945254
Recruitment Status : Completed
First Posted : October 26, 2016
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

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.


Condition or disease Intervention/treatment Phase
Sleep Onset Insomnia Device: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality
Study Start Date : August 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Active Comparator: Background noise
Overnight sleep study with filtered white noise
Device: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
No Intervention: Silence
Overnight sleep study with normal environmental noise



Primary Outcome Measures :
  1. Sleep Onset Latency (Mins) [ Time Frame: 1 night ]
    time from lights out to the first epoch of stage 2 NREM sleep


Secondary Outcome Measures :
  1. Subjective Sleep Quality (VAS) [ Time Frame: 1 night ]
    subjective sleep quality was assessed in the morning with a visual analog scale (VAS) ranging from 1 (worse quality) to 10 (best quality)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 21 and 60

Exclusion Criteria:

  • Any sleep disorder
  • Use of hypnotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945254


Locations
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United States, Massachusetts
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by David Andrew Wellman, Brigham and Women's Hospital:

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Responsible Party: David Andrew Wellman, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02945254     History of Changes
Other Study ID Numbers: 2016P000982
First Posted: October 26, 2016    Key Record Dates
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Andrew Wellman, Brigham and Women's Hospital:
sleep onset latency
sleep quality
insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders