Effect of Background Noise on Sleep Quality (Noise)
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|ClinicalTrials.gov Identifier: NCT02945254|
Recruitment Status : Completed
First Posted : October 26, 2016
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Onset Insomnia||Device: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
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
- Sleep Onset Latency (Mins) [ Time Frame: 1 night ]time from lights out to the first epoch of stage 2 NREM sleep
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945254
|United States, Massachusetts|
|Sleep Disorders Research Program Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|