Effect of Background Noise on Sleep Quality

Sleep Onset Insomnia Clinical Trial

— Noise  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945254
• Other study ID #: 2016P000982
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age between 21 and 60

Exclusion Criteria:

• Any sleep disorder

• Use of hypnotics

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders
• Sleep Onset Insomnia

Intervention

Device:
• NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)

Locations

Country	Name	City	State
United States	Sleep Disorders Research Program Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Onset Latency (Mins)	time from lights out to the first epoch of stage 2 NREM sleep	1 night
Secondary	Subjective Sleep Quality (VAS)	subjective sleep quality was assessed in the morning with a visual analog scale (VAS) ranging from 1 (worse quality) to 10 (best quality)	1 night