Sleep Disorders
Conditions
Keywords
Sleep Apnea, Insomnia, sleep disorders, sleep environment, core body temperature
Brief summary
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.
Interventions
Patients will sleep on this mattress topper during their diagnostic sleep study.
Patients will sleep on this mattress topper during their diagnostic sleep study.
Sponsors
Study design
Eligibility
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | Overnight study visit (up to approximately 10hrs) | — |
| Sleep Efficiency Assessed by Polysomnography (PSG) | Overnight study visit (up to approximately 10hrs) | 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. |
| Sleep Latency Assessed by PSG | Overnight study visit (up to approximately 10hrs) | The amount of time from lights off to falling asleep. |
| Wake After Sleep Onset (WASO) Assessed by PSG | Overnight study visit (up to approximately 10hrs) | Total amount of minutes awake after the first sleep epoch. |
| Percentage of Time in Bed During Each Sleep Stage | Overnight study visit (up to approximately 10hrs) | — |
| Position Changes Assessed by PSG | Overnight study visit (up to approximately 10hrs) | Number of times participant changed position during the sleep recording. |
| Apnea Hypopnea Index Assessed by PSG | Overnight study visit (up to approximately 10hrs) | The number of apneas or hypopneas recorded during the study per hour of sleep. |
| Heart Rate | Overnight study visit (up to approximately 10hrs) | — |
| Periodic Leg Movements (PLM) During Sleep | Overnight study visit (up to approximately 10hrs) | Number of times participant had periodic leg movements during the sleep recording |
| Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | Overnight study visit (up to approximately 10hrs) | EEG data collected from the electrode in position C2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core Body Temperature | Overnight study visit (up to approximately 10hrs) | 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. |
| Visual Analog Scale of Sleep | Overnight study visit (up to approximately 10hrs) | 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). |
| Visual Analog Scale of Performance | Overnight study visit (up to approximately 10hrs) | 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). |
| Visual Analog Scale of Mood | Overnight study visit (up to approximately 10hrs) | visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good). |
| Alliance Sleep Questionnaire (ASQ) | Overnight study visit (up to approximately 10hrs) | self-reported information related to sleep |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from individuals who were scheduled for an overnight PSG study as part of their regular care at the Stanford Sleep clinic.
Pre-assignment details
4 participants were enrolled but not randomized to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| Low Rebound Mattress Toppers Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic. | 281 |
| High Rebound Mattress Toppers Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic. | 273 |
| Total | 554 |
Baseline characteristics
| Characteristic | Low Rebound Mattress Toppers | High Rebound Mattress Toppers | Total |
|---|---|---|---|
| Age, Continuous | 39.42 years STANDARD_DEVIATION 15.84 | 41.27 years STANDARD_DEVIATION 15.93 | 40.28 years STANDARD_DEVIATION 15.89 |
| Body Mass Index | 26.22 kg/m^2 STANDARD_DEVIATION 5.61 | 26.34 kg/m^2 STANDARD_DEVIATION 5.41 | 26.30 kg/m^2 STANDARD_DEVIATION 5.51 |
| Race/Ethnicity, Customized Asian | 44 Participants | 42 Participants | 86 Participants |
| Race/Ethnicity, Customized Black/African American | 8 Participants | 14 Participants | 22 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 18 Participants | 26 Participants | 44 Participants |
| Race/Ethnicity, Customized Multiple | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Native American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 12 Participants | 19 Participants |
| Race/Ethnicity, Customized Participant indicated Multiple and Other | 7 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 186 Participants | 173 Participants | 359 Participants |
| Region of Enrollment United States | 281 Participants | 273 Participants | 554 Participants |
| Room temperature | 20.84 degrees Celsius STANDARD_DEVIATION 1.41 | 20.88 degrees Celsius STANDARD_DEVIATION 1.42 | 20.84 degrees Celsius STANDARD_DEVIATION 1.41 |
| Sex: Female, Male Female | 129 Participants | 135 Participants | 264 Participants |
| Sex: Female, Male Male | 152 Participants | 138 Participants | 290 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 281 | 0 / 273 |
| other Total, other adverse events | 0 / 281 | 0 / 273 |
| serious Total, serious adverse events | 0 / 281 | 0 / 273 |
Outcome results
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Apnea Hypopnea Index Assessed by PSG | 34.15 number of events per hour | Standard Deviation 57 |
| High Rebound Mattress Toppers | Apnea Hypopnea Index Assessed by PSG | 33.86 number of events per hour | Standard Deviation 45.48 |
Heart Rate
Time frame: Overnight study visit (up to approximately 10hrs)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Heart Rate | 61.24 Beats per minute | Standard Deviation 14.19 |
| High Rebound Mattress Toppers | Heart Rate | 64.82 Beats per minute | Standard Deviation 10.48 |
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 0-90min | 31.34 µV^2 | Standard Deviation 30.71 |
| Low Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 90-180min | 28.61 µV^2 | Standard Deviation 31.56 |
| Low Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 180-270min | 24.19 µV^2 | Standard Deviation 31.55 |
| Low Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 270-360min | 21.66 µV^2 | Standard Deviation 38.68 |
| High Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 270-360min | 20.07 µV^2 | Standard Deviation 23.35 |
| High Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 0-90min | 31.93 µV^2 | Standard Deviation 36.61 |
| High Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 180-270min | 27.02 µV^2 | Standard Deviation 67.62 |
| High Rebound Mattress Toppers | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | 90-180min | 32.00 µV^2 | Standard Deviation 32.61 |
Percentage of Time in Bed During Each Sleep Stage
Time frame: Overnight study visit (up to approximately 10hrs)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | REM | 16.26 percentage of time in bed | Standard Deviation 6.96 |
| Low Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Non REM stage 2 | 47.67 percentage of time in bed | Standard Deviation 12.22 |
| Low Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Non REM stage 1 | 6.36 percentage of time in bed | Standard Deviation 4.83 |
| Low Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Non REM stage 3 | 11.86 percentage of time in bed | Standard Deviation 10.58 |
| Low Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Wake | 17.11 percentage of time in bed | Standard Deviation 11.38 |
| High Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Non REM stage 3 | 11.81 percentage of time in bed | Standard Deviation 16.09 |
| High Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Wake | 20.16 percentage of time in bed | Standard Deviation 14.92 |
| High Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | REM | 14.92 percentage of time in bed | Standard Deviation 7.52 |
| High Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Non REM stage 1 | 6.46 percentage of time in bed | Standard Deviation 4.58 |
| High Rebound Mattress Toppers | Percentage of Time in Bed During Each Sleep Stage | Non REM stage 2 | 47.36 percentage of time in bed | Standard Deviation 12.69 |
Periodic Leg Movements (PLM) During Sleep
Number of times participant had periodic leg movements during the sleep recording
Time frame: Overnight study visit (up to approximately 10hrs)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Periodic Leg Movements (PLM) During Sleep | 99.56 number of PLM events | Standard Deviation 143.43 |
| High Rebound Mattress Toppers | Periodic Leg Movements (PLM) During Sleep | 91.51 number of PLM events | Standard Deviation 11.36 |
Position Changes Assessed by PSG
Number of times participant changed position during the sleep recording.
Time frame: Overnight study visit (up to approximately 10hrs)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Position Changes Assessed by PSG | 14.64 number of position changes | Standard Deviation 12.76 |
| High Rebound Mattress Toppers | Position Changes Assessed by PSG | 15.65 number of position changes | Standard Deviation 10.45 |
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Sleep Efficiency Assessed by Polysomnography (PSG) | 82.87 percentage time in bed asleep | Standard Deviation 11.34 |
| High Rebound Mattress Toppers | Sleep Efficiency Assessed by Polysomnography (PSG) | 79.73 percentage time in bed asleep | Standard Deviation 14.94 |
Sleep Latency Assessed by PSG
The amount of time from lights off to falling asleep.
Time frame: Overnight study visit (up to approximately 10hrs)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Sleep Latency Assessed by PSG | 18.67 minutes | Standard Deviation 21 |
| High Rebound Mattress Toppers | Sleep Latency Assessed by PSG | 24.05 minutes | Standard Deviation 25.31 |
Total Sleep Time
Time frame: Overnight study visit (up to approximately 10hrs)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Total Sleep Time | 6.62 hours | Standard Deviation 1.25 |
| High Rebound Mattress Toppers | Total Sleep Time | 6.55 hours | Standard Deviation 1.59 |
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Wake After Sleep Onset (WASO) Assessed by PSG | 60.09 minutes | Standard Deviation 43.57 |
| High Rebound Mattress Toppers | Wake After Sleep Onset (WASO) Assessed by PSG | 74.36 minutes | Standard Deviation 67.55 |
Alliance Sleep Questionnaire (ASQ)
self-reported information related to sleep
Time frame: Overnight study visit (up to approximately 10hrs)
Population: Data were not collected for this outcome measure.
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Rebound Mattress Toppers | Core Body Temperature | 30min since lights off | 36.42 degrees Celsius | Standard Deviation 1.15 |
| Low Rebound Mattress Toppers | Core Body Temperature | 60min since lights off | 36.49 degrees Celsius | Standard Deviation 0.34 |
| Low Rebound Mattress Toppers | Core Body Temperature | 90min since lights off | 36.46 degrees Celsius | Standard Deviation 0.34 |
| Low Rebound Mattress Toppers | Core Body Temperature | 120min since lights off | 36.47 degrees Celsius | Standard Deviation 0.33 |
| Low Rebound Mattress Toppers | Core Body Temperature | 150min since lights off | 36.51 degrees Celsius | Standard Deviation 0.33 |
| Low Rebound Mattress Toppers | Core Body Temperature | 180min since lights off | 36.54 degrees Celsius | Standard Deviation 0.32 |
| Low Rebound Mattress Toppers | Core Body Temperature | 210min since lights off | 36.56 degrees Celsius | Standard Deviation 0.33 |
| Low Rebound Mattress Toppers | Core Body Temperature | 240min since lights off | 36.59 degrees Celsius | Standard Deviation 0.31 |
| Low Rebound Mattress Toppers | Core Body Temperature | 270min since lights off | 36.58 degrees Celsius | Standard Deviation 0.36 |
| Low Rebound Mattress Toppers | Core Body Temperature | 300min since lights off | 36.59 degrees Celsius | Standard Deviation 0.33 |
| Low Rebound Mattress Toppers | Core Body Temperature | 330min since lights off | 36.61 degrees Celsius | Standard Deviation 0.28 |
| Low Rebound Mattress Toppers | Core Body Temperature | 360min since lights off | 36.62 degrees Celsius | Standard Deviation 0.28 |
| High Rebound Mattress Toppers | Core Body Temperature | 330min since lights off | 36.64 degrees Celsius | Standard Deviation 0.29 |
| High Rebound Mattress Toppers | Core Body Temperature | 30min since lights off | 36.29 degrees Celsius | Standard Deviation 1.23 |
| High Rebound Mattress Toppers | Core Body Temperature | 210min since lights off | 36.57 degrees Celsius | Standard Deviation 0.3 |
| High Rebound Mattress Toppers | Core Body Temperature | 60min since lights off | 36.52 degrees Celsius | Standard Deviation 0.34 |
| High Rebound Mattress Toppers | Core Body Temperature | 300min since lights off | 36.65 degrees Celsius | Standard Deviation 0.3 |
| High Rebound Mattress Toppers | Core Body Temperature | 90min since lights off | 36.49 degrees Celsius | Standard Deviation 0.35 |
| High Rebound Mattress Toppers | Core Body Temperature | 240min since lights off | 36.61 degrees Celsius | Standard Deviation 0.32 |
| High Rebound Mattress Toppers | Core Body Temperature | 120min since lights off | 36.51 degrees Celsius | Standard Deviation 0.34 |
| High Rebound Mattress Toppers | Core Body Temperature | 360min since lights off | 36.63 degrees Celsius | Standard Deviation 0.29 |
| High Rebound Mattress Toppers | Core Body Temperature | 150min since lights off | 36.53 degrees Celsius | Standard Deviation 0.32 |
| High Rebound Mattress Toppers | Core Body Temperature | 270min since lights off | 36.64 degrees Celsius | Standard Deviation 0.38 |
| High Rebound Mattress Toppers | Core Body Temperature | 180min since lights off | 36.56 degrees Celsius | Standard Deviation 0.31 |
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Visual Analog Scale of Mood | 6.60 units on a scale | Standard Deviation 2.06 |
| High Rebound Mattress Toppers | Visual Analog Scale of Mood | 6.60 units on a scale | Standard Deviation 2.03 |
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Visual Analog Scale of Performance | 5.54 units on a scale | Standard Deviation 2.21 |
| High Rebound Mattress Toppers | Visual Analog Scale of Performance | 5.45 units on a scale | Standard Deviation 2.35 |
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)
Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rebound Mattress Toppers | Visual Analog Scale of Sleep | 4.93 units on a scale | Standard Deviation 2.33 |
| High Rebound Mattress Toppers | Visual Analog Scale of Sleep | 4.80 units on a scale | Standard Deviation 2.45 |