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Clinical Trials/NCT02945254
NCT02945254
Completed
Phase 1

Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality

Brigham and Women's Hospital1 site in 1 country20 target enrollmentAugust 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Sleep Onset Insomnia
Sponsor
Brigham and Women's Hospital
Enrollment
20
Locations
1
Primary Endpoint
Sleep Onset Latency (Mins)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
February 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Andrew Wellman

MD, PhD

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Age between 21 and 60

Exclusion Criteria

  • Any sleep disorder
  • Use of hypnotics

Outcomes

Primary Outcomes

Sleep Onset Latency (Mins)

Time Frame: 1 night

time from lights out to the first epoch of stage 2 NREM sleep

Secondary Outcomes

  • Subjective Sleep Quality (VAS)(1 night)

Study Sites (1)

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