Effect of Background Noise on Sleep Quality

Phase 1

Completed

• Conditions: Sleep Onset Insomnia
• Interventions: Device: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)

• Registration Number: NCT02945254
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Results First Submitted: 2018-03-08
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-24
• Last Update Submitted: 2018-05-24
• Results First Posted: 2018-05-25
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age between 21 and 60

Exclusion Criteria

• Any sleep disorder
• Use of hypnotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Background noise	NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)	Overnight sleep study with filtered white noise

Primary Outcome Measures

Name	Time	Method
Sleep Onset Latency (Mins)	1 night	time from lights out to the first epoch of stage 2 NREM sleep

Secondary Outcome Measures

Name	Time	Method
Subjective Sleep Quality (VAS)	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)

Trial Locations

Locations (1)

Sleep Disorders Research Program Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States