Effect of Background Noise on Sleep Quality (Noise)
Primary Purpose
Sleep Onset Insomnia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Onset Insomnia focused on measuring sleep onset latency, sleep quality, insomnia
Eligibility Criteria
Inclusion Criteria:
- Age between 21 and 60
Exclusion Criteria:
- Any sleep disorder
- Use of hypnotics
Sites / Locations
- Sleep Disorders Research Program Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Background noise
Silence
Arm Description
Overnight sleep study with filtered white noise
Overnight sleep study with normal environmental noise
Outcomes
Primary Outcome Measures
Sleep Onset Latency (Mins)
time from lights out to the first epoch of stage 2 NREM sleep
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02945254
First Posted
October 25, 2016
Last Updated
May 24, 2018
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02945254
Brief Title
Effect of Background Noise on Sleep Quality
Acronym
Noise
Official Title
Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Onset Insomnia
Keywords
sleep onset latency, sleep quality, insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Background noise
Arm Type
Active Comparator
Arm Description
Overnight sleep study with filtered white noise
Arm Title
Silence
Arm Type
No Intervention
Arm Description
Overnight sleep study with normal environmental noise
Intervention Type
Device
Intervention Name(s)
NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
Primary Outcome Measure Information:
Title
Sleep Onset Latency (Mins)
Description
time from lights out to the first epoch of stage 2 NREM sleep
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Subjective Sleep Quality (VAS)
Description
subjective sleep quality was assessed in the morning with a visual analog scale (VAS) ranging from 1 (worse quality) to 10 (best quality)
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 21 and 60
Exclusion Criteria:
Any sleep disorder
Use of hypnotics
Facility Information:
Facility Name
Sleep Disorders Research Program Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Background Noise on Sleep Quality
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