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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
558
Patients will sleep on this mattress topper during their diagnostic sleep study.
Patients will sleep on this mattress topper during their diagnostic sleep study.
Stanford Sleep Research Center
Stanford, California, United States
Total Sleep Time
Time frame: 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.
Time frame: Overnight study visit (up to approximately 10hrs)
Sleep Latency Assessed by PSG
The amount of time from lights off to falling asleep.
Time frame: 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.
Time frame: Overnight study visit (up to approximately 10hrs)
Percentage of Time in Bed During Each Sleep Stage
Time frame: Overnight study visit (up to approximately 10hrs)
Position Changes Assessed by PSG
Number of times participant changed position during the sleep recording.
Time frame: 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.
Time frame: Overnight study visit (up to approximately 10hrs)
Heart Rate
Time frame: Overnight study visit (up to approximately 10hrs)
Periodic Leg Movements (PLM) During Sleep
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Number of times participant had periodic leg movements during the sleep recording
Time frame: 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
Time frame: Overnight study visit (up to approximately 10hrs)
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Overnight study visit (up to approximately 10hrs)
Alliance Sleep Questionnaire (ASQ)
self-reported information related to sleep
Time frame: Overnight study visit (up to approximately 10hrs)