Effect of Background Noise on Sleep Quality (Noise)

May 24, 2018 updated by: David Andrew Wellman, Brigham and Women's Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Sleep Disorders Research Program Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 21 and 60

Exclusion Criteria:

  • Any sleep disorder
  • Use of hypnotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Onset Latency (Mins)
Time Frame: 1 night
time from lights out to the first epoch of stage 2 NREM sleep
1 night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (ESTIMATE)

October 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P000982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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