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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03055156
Enrollment
558
Registered
2017-02-16
Start date
2015-10-31
Completion date
2019-10-19
Last updated
2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

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

DEVICELow rebound mattress toppers

Patients will sleep on this mattress topper during their diagnostic sleep study.

DEVICEHigh rebound mattress toppers

Patients will sleep on this mattress topper during their diagnostic sleep study.

Sponsors

Airweave Pte Ltd.
CollaboratorINDUSTRY
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Total Sleep TimeOvernight 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 PSGOvernight study visit (up to approximately 10hrs)The amount of time from lights off to falling asleep.
Wake After Sleep Onset (WASO) Assessed by PSGOvernight study visit (up to approximately 10hrs)Total amount of minutes awake after the first sleep epoch.
Percentage of Time in Bed During Each Sleep StageOvernight study visit (up to approximately 10hrs)
Position Changes Assessed by PSGOvernight study visit (up to approximately 10hrs)Number of times participant changed position during the sleep recording.
Apnea Hypopnea Index Assessed by PSGOvernight study visit (up to approximately 10hrs)The number of apneas or hypopneas recorded during the study per hour of sleep.
Heart RateOvernight study visit (up to approximately 10hrs)
Periodic Leg Movements (PLM) During SleepOvernight 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 OffOvernight study visit (up to approximately 10hrs)EEG data collected from the electrode in position C2

Secondary

MeasureTime frameDescription
Core Body TemperatureOvernight 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 SleepOvernight 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 PerformanceOvernight 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 MoodOvernight 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

ArmCount
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
Total554

Baseline characteristics

CharacteristicLow Rebound Mattress ToppersHigh Rebound Mattress ToppersTotal
Age, Continuous39.42 years
STANDARD_DEVIATION 15.84
41.27 years
STANDARD_DEVIATION 15.93
40.28 years
STANDARD_DEVIATION 15.89
Body Mass Index26.22 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 Participants42 Participants86 Participants
Race/Ethnicity, Customized
Black/African American
8 Participants14 Participants22 Participants
Race/Ethnicity, Customized
Hispanic/Latino
18 Participants26 Participants44 Participants
Race/Ethnicity, Customized
Multiple
7 Participants4 Participants11 Participants
Race/Ethnicity, Customized
Native American
2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Other
7 Participants12 Participants19 Participants
Race/Ethnicity, Customized
Participant indicated Multiple and Other
7 Participants2 Participants9 Participants
Race/Ethnicity, Customized
Unknown
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White/Caucasian
186 Participants173 Participants359 Participants
Region of Enrollment
United States
281 Participants273 Participants554 Participants
Room temperature20.84 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 Participants135 Participants264 Participants
Sex: Female, Male
Male
152 Participants138 Participants290 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2810 / 273
other
Total, other adverse events
0 / 2810 / 273
serious
Total, serious adverse events
0 / 2810 / 273

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersApnea Hypopnea Index Assessed by PSG34.15 number of events per hourStandard Deviation 57
High Rebound Mattress ToppersApnea Hypopnea Index Assessed by PSG33.86 number of events per hourStandard Deviation 45.48
p-value: 0.96t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersHeart Rate61.24 Beats per minuteStandard Deviation 14.19
High Rebound Mattress ToppersHeart Rate64.82 Beats per minuteStandard Deviation 10.48
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Low Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off0-90min31.34 µV^2Standard Deviation 30.71
Low Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off90-180min28.61 µV^2Standard Deviation 31.56
Low Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off180-270min24.19 µV^2Standard Deviation 31.55
Low Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off270-360min21.66 µV^2Standard Deviation 38.68
High Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off270-360min20.07 µV^2Standard Deviation 23.35
High Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off0-90min31.93 µV^2Standard Deviation 36.61
High Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off180-270min27.02 µV^2Standard Deviation 67.62
High Rebound Mattress ToppersMean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off90-180min32.00 µV^2Standard Deviation 32.61
Comparison: analysis of 0-90 minutesp-value: 0.86t-test, 2 sided
Comparison: analysis of 90-180 minutesp-value: 0.29t-test, 2 sided
Comparison: analysis of 180-270 minutesp-value: 0.58t-test, 2 sided
Comparison: analysis of 270-360 minp-value: 0.62t-test, 2 sided
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Low Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageREM16.26 percentage of time in bedStandard Deviation 6.96
Low Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageNon REM stage 247.67 percentage of time in bedStandard Deviation 12.22
Low Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageNon REM stage 16.36 percentage of time in bedStandard Deviation 4.83
Low Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageNon REM stage 311.86 percentage of time in bedStandard Deviation 10.58
Low Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageWake17.11 percentage of time in bedStandard Deviation 11.38
High Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageNon REM stage 311.81 percentage of time in bedStandard Deviation 16.09
High Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageWake20.16 percentage of time in bedStandard Deviation 14.92
High Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageREM14.92 percentage of time in bedStandard Deviation 7.52
High Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageNon REM stage 16.46 percentage of time in bedStandard Deviation 4.58
High Rebound Mattress ToppersPercentage of Time in Bed During Each Sleep StageNon REM stage 247.36 percentage of time in bedStandard Deviation 12.69
Comparison: Analysis of Wake valuesp-value: 0.02t-test, 2 sided
Comparison: Analysis of REM valuesp-value: 0.06t-test, 2 sided
Comparison: Analysis of Non REM stage 1 valuesp-value: 0.83t-test, 2 sided
Comparison: Analysis of Non REM stage 2 valuesp-value: 0.87t-test, 2 sided
Comparison: Analysis of Non REM stage 3 valuesp-value: 0.97t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersPeriodic Leg Movements (PLM) During Sleep99.56 number of PLM eventsStandard Deviation 143.43
High Rebound Mattress ToppersPeriodic Leg Movements (PLM) During Sleep91.51 number of PLM eventsStandard Deviation 11.36
p-value: 0.55t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersPosition Changes Assessed by PSG14.64 number of position changesStandard Deviation 12.76
High Rebound Mattress ToppersPosition Changes Assessed by PSG15.65 number of position changesStandard Deviation 10.45
p-value: 0.38t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersSleep Efficiency Assessed by Polysomnography (PSG)82.87 percentage time in bed asleepStandard Deviation 11.34
High Rebound Mattress ToppersSleep Efficiency Assessed by Polysomnography (PSG)79.73 percentage time in bed asleepStandard Deviation 14.94
p-value: 0.02t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersSleep Latency Assessed by PSG18.67 minutesStandard Deviation 21
High Rebound Mattress ToppersSleep Latency Assessed by PSG24.05 minutesStandard Deviation 25.31
p-value: 0.02t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersTotal Sleep Time6.62 hoursStandard Deviation 1.25
High Rebound Mattress ToppersTotal Sleep Time6.55 hoursStandard Deviation 1.59
p-value: 0.6t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersWake After Sleep Onset (WASO) Assessed by PSG60.09 minutesStandard Deviation 43.57
High Rebound Mattress ToppersWake After Sleep Onset (WASO) Assessed by PSG74.36 minutesStandard Deviation 67.55
p-value: 0.01t-test, 2 sided
Secondary

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.

Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Low Rebound Mattress ToppersCore Body Temperature30min since lights off36.42 degrees CelsiusStandard Deviation 1.15
Low Rebound Mattress ToppersCore Body Temperature60min since lights off36.49 degrees CelsiusStandard Deviation 0.34
Low Rebound Mattress ToppersCore Body Temperature90min since lights off36.46 degrees CelsiusStandard Deviation 0.34
Low Rebound Mattress ToppersCore Body Temperature120min since lights off36.47 degrees CelsiusStandard Deviation 0.33
Low Rebound Mattress ToppersCore Body Temperature150min since lights off36.51 degrees CelsiusStandard Deviation 0.33
Low Rebound Mattress ToppersCore Body Temperature180min since lights off36.54 degrees CelsiusStandard Deviation 0.32
Low Rebound Mattress ToppersCore Body Temperature210min since lights off36.56 degrees CelsiusStandard Deviation 0.33
Low Rebound Mattress ToppersCore Body Temperature240min since lights off36.59 degrees CelsiusStandard Deviation 0.31
Low Rebound Mattress ToppersCore Body Temperature270min since lights off36.58 degrees CelsiusStandard Deviation 0.36
Low Rebound Mattress ToppersCore Body Temperature300min since lights off36.59 degrees CelsiusStandard Deviation 0.33
Low Rebound Mattress ToppersCore Body Temperature330min since lights off36.61 degrees CelsiusStandard Deviation 0.28
Low Rebound Mattress ToppersCore Body Temperature360min since lights off36.62 degrees CelsiusStandard Deviation 0.28
High Rebound Mattress ToppersCore Body Temperature330min since lights off36.64 degrees CelsiusStandard Deviation 0.29
High Rebound Mattress ToppersCore Body Temperature30min since lights off36.29 degrees CelsiusStandard Deviation 1.23
High Rebound Mattress ToppersCore Body Temperature210min since lights off36.57 degrees CelsiusStandard Deviation 0.3
High Rebound Mattress ToppersCore Body Temperature60min since lights off36.52 degrees CelsiusStandard Deviation 0.34
High Rebound Mattress ToppersCore Body Temperature300min since lights off36.65 degrees CelsiusStandard Deviation 0.3
High Rebound Mattress ToppersCore Body Temperature90min since lights off36.49 degrees CelsiusStandard Deviation 0.35
High Rebound Mattress ToppersCore Body Temperature240min since lights off36.61 degrees CelsiusStandard Deviation 0.32
High Rebound Mattress ToppersCore Body Temperature120min since lights off36.51 degrees CelsiusStandard Deviation 0.34
High Rebound Mattress ToppersCore Body Temperature360min since lights off36.63 degrees CelsiusStandard Deviation 0.29
High Rebound Mattress ToppersCore Body Temperature150min since lights off36.53 degrees CelsiusStandard Deviation 0.32
High Rebound Mattress ToppersCore Body Temperature270min since lights off36.64 degrees CelsiusStandard Deviation 0.38
High Rebound Mattress ToppersCore Body Temperature180min since lights off36.56 degrees CelsiusStandard Deviation 0.31
Comparison: Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to compare the difference in core body temperature trend over time between the two study arms. Interaction between time and topper type on CBT was calculated.p-value: 0.389ANOVA
Comparison: Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.p-value: 0.01ANOVA
Comparison: Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT.p-value: 0.642ANOVA
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersVisual Analog Scale of Mood6.60 units on a scaleStandard Deviation 2.06
High Rebound Mattress ToppersVisual Analog Scale of Mood6.60 units on a scaleStandard Deviation 2.03
p-value: 1t-test, 2 sided
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersVisual Analog Scale of Performance5.54 units on a scaleStandard Deviation 2.21
High Rebound Mattress ToppersVisual Analog Scale of Performance5.45 units on a scaleStandard Deviation 2.35
p-value: 0.71t-test, 2 sided
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Low Rebound Mattress ToppersVisual Analog Scale of Sleep4.93 units on a scaleStandard Deviation 2.33
High Rebound Mattress ToppersVisual Analog Scale of Sleep4.80 units on a scaleStandard Deviation 2.45
p-value: 0.61t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026