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CompletedNCT03055156Updated Nov 6, 2020Results posted

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

An interventional study of Low rebound mattress toppers and High rebound mattress toppers in Sleep Disorders, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by Stanford University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
558
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Disorders

Keywords

  • Sleep Apnea
  • Insomnia
  • sleep disorders
  • sleep environment
  • core body temperature
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 558 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
558 participants (actual)

Study arms

  • Experimental
    Low rebound mattress toppers

    sleep with mattress topper during overnight diagnostic sleep study

    Device: Low rebound mattress toppers

  • Experimental
    High rebound mattress toppers

    sleep with mattress topper during overnight diagnostic sleep study

    Device: High rebound mattress toppers

Interventions

  • DeviceLow rebound mattress toppers

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

    Also known as: TEMPUR-Topper Supreme

  • DeviceHigh rebound mattress toppers

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

    Also known as: airweave® mattress topper

06

What researchers measure

Primary outcomes

  1. Total Sleep Time

    Time frame: Overnight study visit (up to approximately 10hrs)

  2. 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)

  3. Sleep Latency Assessed by PSG

    The amount of time from lights off to falling asleep.

    Time frame: Overnight study visit (up to approximately 10hrs)

  4. 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)

  5. Percentage of Time in Bed During Each Sleep Stage

    Time frame: Overnight study visit (up to approximately 10hrs)

  6. Position Changes Assessed by PSG

    Number of times participant changed position during the sleep recording.

    Time frame: Overnight study visit (up to approximately 10hrs)

  7. 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)

  8. Heart Rate

    Time frame: Overnight study visit (up to approximately 10hrs)

  9. 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)

  10. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Alliance Sleep Questionnaire (ASQ)

    self-reported information related to sleep

    Time frame: Overnight study visit (up to approximately 10hrs)

07

Results

Posted Nov 6, 2020

Participant flow

Participants were recruited from individuals who were scheduled for an overnight PSG study as part of their regular care at the Stanford Sleep clinic.

Participant flow — Overall Study
MilestoneLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Started281273
Completed281273
Not completed00

Outcome measures

PrimaryTotal Sleep Time
Time frame:
Overnight study visit (up to approximately 10hrs)
Reported as:
Mean · hours
Total Sleep Time
hoursLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Total Sleep Time6.62 ± 1.256.55 ± 1.59
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.60
PrimarySleep 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)
Reported as:
Mean · percentage time in bed asleep
Sleep Efficiency Assessed by Polysomnography (PSG)
percentage time in bed asleepLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Sleep Efficiency Assessed by Polysomnography (PSG)82.87 ± 11.3479.73 ± 14.94
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.02
PrimarySleep Latency Assessed by PSG

The amount of time from lights off to falling asleep.

Time frame:
Overnight study visit (up to approximately 10hrs)
Reported as:
Mean · minutes
Sleep Latency Assessed by PSG
minutesLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Sleep Latency Assessed by PSG18.67 ± 21.0024.05 ± 25.31
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.02
PrimaryWake 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)
Reported as:
Mean · minutes
Wake After Sleep Onset (WASO) Assessed by PSG
minutesLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Wake After Sleep Onset (WASO) Assessed by PSG60.09 ± 43.5774.36 ± 67.55
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.01
PrimaryPercentage of Time in Bed During Each Sleep Stage
Time frame:
Overnight study visit (up to approximately 10hrs)
Reported as:
Mean · percentage of time in bed
Percentage of Time in Bed During Each Sleep Stage
percentage of time in bedLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Wake17.11 ± 11.3820.16 ± 14.92
REM16.26 ± 6.9614.92 ± 7.52
Non REM stage 16.36 ± 4.836.46 ± 4.58
Non REM stage 247.67 ± 12.2247.36 ± 12.69
Non REM stage 311.86 ± 10.5811.81 ± 16.09
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.02
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.06
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.83
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.87
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.97
PrimaryPosition Changes Assessed by PSG

Number of times participant changed position during the sleep recording.

Time frame:
Overnight study visit (up to approximately 10hrs)
Reported as:
Mean · number of position changes
Position Changes Assessed by PSG
number of position changesLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Position Changes Assessed by PSG14.64 ± 12.7615.65 ± 10.45
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.38
PrimaryApnea 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)
Reported as:
Mean · number of events per hour
Apnea Hypopnea Index Assessed by PSG
number of events per hourLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Apnea Hypopnea Index Assessed by PSG34.15 ± 57.0033.86 ± 45.48
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.96
PrimaryHeart Rate
Time frame:
Overnight study visit (up to approximately 10hrs)
Reported as:
Mean · Beats per minute
Heart Rate
Beats per minuteLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Heart Rate61.24 ± 14.1964.82 ± 10.48
PrimaryPeriodic 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)
Reported as:
Mean · number of PLM events
Periodic Leg Movements (PLM) During Sleep
number of PLM eventsLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Periodic Leg Movements (PLM) During Sleep99.56 ± 143.4391.51 ± 11.36
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.55
PrimaryMean 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)
Reported as:
Mean · µV^2
Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
µV^2Low Rebound Mattress ToppersHigh Rebound Mattress Toppers
0-90min31.34 ± 30.7131.93 ± 36.61
90-180min28.61 ± 31.5632.00 ± 32.61
180-270min24.19 ± 31.5527.02 ± 67.62
270-360min21.66 ± 38.6820.07 ± 23.35
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.86
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.29
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.58
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.62
SecondaryCore 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)
Reported as:
Mean · degrees Celsius
Core Body Temperature
degrees CelsiusLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
30min since lights off36.42 ± 1.1536.29 ± 1.23
60min since lights off36.49 ± 0.3436.52 ± 0.34
90min since lights off36.46 ± 0.3436.49 ± 0.35
120min since lights off36.47 ± 0.3336.51 ± 0.34
150min since lights off36.51 ± 0.3336.53 ± 0.32
180min since lights off36.54 ± 0.3236.56 ± 0.31
210min since lights off36.56 ± 0.3336.57 ± 0.30
240min since lights off36.59 ± 0.3136.61 ± 0.32
270min since lights off36.58 ± 0.3636.64 ± 0.38
300min since lights off36.59 ± 0.3336.65 ± 0.30
330min since lights off36.61 ± 0.2836.64 ± 0.29
360min since lights off36.62 ± 0.2836.63 ± 0.29
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · ANOVA · p = 0.389
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · ANOVA · p = 0.01
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · ANOVA · p = 0.642
SecondaryVisual 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)
Reported as:
Mean · units on a scale
Visual Analog Scale of Sleep
units on a scaleLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Visual Analog Scale of Sleep4.93 ± 2.334.80 ± 2.45
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.61
SecondaryVisual 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)
Reported as:
Mean · units on a scale
Visual Analog Scale of Performance
units on a scaleLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Visual Analog Scale of Performance5.54 ± 2.215.45 ± 2.35
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 0.71
SecondaryVisual 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)
Reported as:
Mean · units on a scale
Visual Analog Scale of Mood
units on a scaleLow Rebound Mattress ToppersHigh Rebound Mattress Toppers
Visual Analog Scale of Mood6.60 ± 2.066.60 ± 2.03
Statistical analysis
  • Low Rebound Mattress Toppers vs High Rebound Mattress Toppers · t-test, 2 sided · p = 1.00
SecondaryAlliance Sleep Questionnaire (ASQ)

self-reported information related to sleep

Time frame:
Overnight study visit (up to approximately 10hrs)

No measurements were reported for this outcome.

Adverse events

Collected over Study visit overnight (up to 24hrs). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Low Rebound Mattress Toppers0/281 (0%)0/281 (0%)0/281 (0%)
High Rebound Mattress Toppers0/273 (0%)0/273 (0%)0/273 (0%)

Baseline characteristics

Randomized participants

Age, Continuous
Age, Continuous(years)Low Rebound Mattress ToppersHigh Rebound Mattress ToppersTotal
Mean39.42 ± 15.8441.27 ± 15.9340.28 ± 15.89
Sex: Female, Male
Sex: Female, Male(Participants)Low Rebound Mattress ToppersHigh Rebound Mattress ToppersTotal
Female129135264
Male152138290
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Low Rebound Mattress ToppersHigh Rebound Mattress ToppersTotal
Asian444286
Black/African American81422
Hispanic/Latino182644
Native Hawaiian/Pacific Islander123
Native American202
White/Caucasian186173359
Multiple7411
Unknown101
Other71219
Participant indicated Multiple and Other729
Region of Enrollment
Region of Enrollment(Participants)Low Rebound Mattress ToppersHigh Rebound Mattress ToppersTotal
United States281273554
Body Mass Index
Body Mass Index(kg/m^2)Low Rebound Mattress ToppersHigh Rebound Mattress ToppersTotal
Mean26.22 ± 5.6126.34 ± 5.4126.30 ± 5.51
Room temperature
Room temperature(degrees Celsius)Low Rebound Mattress ToppersHigh Rebound Mattress ToppersTotal
Mean20.84 ± 1.4120.88 ± 1.4220.84 ± 1.41
08

Study locations

1 site
  • Stanford Sleep Research Center
    Stanford, California 94305, United States
09

References and documents

Study documents

  • Study protocol · Aug 4, 2015
  • Statistical analysis plan · Oct 13, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03055156
Lead sponsor
Stanford University
Collaborators
Airweave Pte Ltd.
Responsible party
Seiji Nishino (Professor, Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford University) — Principal investigator
First posted
Feb 16, 2017
Start date
Oct 2015
Primary completion
Oct 19, 2019
Completion
Oct 19, 2019
Results posted
Nov 6, 2020
Last update
Nov 6, 2020

Study contacts

Seiji Nishino, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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