Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms

Study Overview
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Brief Summary
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The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e., airweave®) on sleep and sleep-related symptoms. The study will compare effects of use of high rebound mattress toppers versus use of low rebound mattress toppers on sleep and sleep related symptoms and core body temperature during diagnostic sleep studies.

Official Title
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Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms

Conditions
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Sleep Disorders

Intervention / Treatment
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* Device: Low rebound mattress toppers
* Device: High rebound mattress toppers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Age 18-65 who are scheduled for a diagnostic sleep study at the Stanford Sleep Clinic for sleep disorders (including but not limited to, insomnia, Sleep Apnea or other sleep disorder symptoms). Exclusion Criteria: Individuals with a history of having difficulty swallowing food or large capsules. We will not be able to enroll individuals with any known or suspected obstructive disease of the gastrointestinal tract including, but not limited to esophageal stricture, diverticulosis and inflammatory bowel disease (IBD), peptic ulcer disease, Crohn's disease, ulcerative colitis, previous gastrointestinal surgery. Individuals who are pregnant. Individuals who are unable to provide informed consent (i.e. decisionally impaired).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low rebound mattress toppers<br>sleep with mattress topper during overnight diagnostic sleep study | Device: Low rebound mattress toppers<br>* Patients will sleep on this mattress topper during their diagnostic sleep study.<br>* Other names: TEMPUR-Topper Supreme;|
| Experimental: High rebound mattress toppers<br>sleep with mattress topper during overnight diagnostic sleep study | Device: High rebound mattress toppers<br>* Patients will sleep on this mattress topper during their diagnostic sleep study.<br>* Other names: airweave® mattress topper;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time |  | Overnight study visit (up to approximately 10hrs) | 
| Sleep Efficiency Assessed by Polysomnography (PSG) | Sleep efficiency is total sleep time divided by time in bed. All data were collected through the PSG data that were retrieved from the patients' medical records after completion of the recordings and analysis by the sleep technologists. | Overnight study visit (up to approximately 10hrs) | 
| Sleep Latency Assessed by PSG | The amount of time from lights off to falling asleep. | Overnight study visit (up to approximately 10hrs) | 
| Wake After Sleep Onset (WASO) Assessed by PSG | Total amount of minutes awake after the first sleep epoch. | Overnight study visit (up to approximately 10hrs) | 
| Percentage of Time in Bed During Each Sleep Stage |  | Overnight study visit (up to approximately 10hrs) | 
| Position Changes Assessed by PSG | Number of times participant changed position during the sleep recording. | Overnight study visit (up to approximately 10hrs) | 
| Apnea Hypopnea Index Assessed by PSG | The number of apneas or hypopneas recorded during the study per hour of sleep. | Overnight study visit (up to approximately 10hrs) | 
| Heart Rate |  | Overnight study visit (up to approximately 10hrs) | 
| Periodic Leg Movements (PLM) During Sleep | Number of times participant had periodic leg movements during the sleep recording | Overnight study visit (up to approximately 10hrs) | 
| Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | EEG data collected from the electrode in position C2 | Overnight study visit (up to approximately 10hrs) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core Body Temperature | Difference in core body temperature changes of the high and low rebound mattress toppers at sleep onset and during sleep. The core body temperature will be monitored every minute throughout the night. | Overnight study visit (up to approximately 10hrs) | 
| Visual Analog Scale of Sleep | visual analog scale of sleep was used for evaluation of subjective sleep quality. Scale ranged from 0 cm (very bad) to 10 cm (very good). | Overnight study visit (up to approximately 10hrs) | 
| Visual Analog Scale of Performance | visual analog scale of performance was used for evaluation of subjective performance quality. Scale ranged from 0 cm (very bad) to 10 cm (very good). | Overnight study visit (up to approximately 10hrs) | 
| Visual Analog Scale of Mood | visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good). | Overnight study visit (up to approximately 10hrs) | 
| Alliance Sleep Questionnaire (ASQ) | self-reported information related to sleep | Overnight study visit (up to approximately 10hrs) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea, Insomnia, sleep disorders, sleep environment, core body temperature