Effect of Background Noise on Sleep Quality

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Onset Insomnia

Intervention / Treatment
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* Device: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 21 and 60 Exclusion Criteria: Any sleep disorder Use of hypnotics

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Background noise<br>Overnight sleep study with filtered white noise | Device: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)<br> <br> |
| No Intervention: Silence<br>Overnight sleep study with normal environmental noise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Onset Latency (Mins) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep onset latency, sleep quality, insomnia