Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Sleep Onset Latency (Mins)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 21 and 60
Exclusion Criteria
- •Any sleep disorder
- •Use of hypnotics
Arms & Interventions
Background noise
Overnight sleep study with filtered white noise
Intervention: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) (Device)
Silence
Overnight sleep study with normal environmental noise
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)
Investigators
David Andrew Wellman
MD, PhD
Brigham and Women's Hospital