Sleep DisordersNCT03055156

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

A study testing Low rebound mattress toppers and High rebound mattress toppers in people with Sleep Disorders, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Sleep Disorders
What is being tested?: Low rebound mattress toppers and High rebound mattress toppers
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 558 participants
Where: 1 siteUnited States
Study dates: Oct 2015to 19 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Sleep Research Center
Stanford, California, 94305

Other trials in United States

About this study

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.

Conditions: Sleep Disorders
Being tested: Low rebound mattress toppers, High rebound mattress toppers
Keywords: Sleep Apnea, Insomnia, sleep disorders, sleep environment, core body temperature
Medical subject headings: Sleep Wake Disorders, Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low rebound mattress toppersDevice
Also called TEMPUR-Topper Supreme
Patients will sleep on this mattress topper during their diagnostic sleep study.
High rebound mattress toppersDevice
Also called airweave® mattress topper
Patients will sleep on this mattress topper during their diagnostic sleep study.

Study groups in NCT03055156
Study group	Role	What they receive
Low rebound mattress toppers	Experimental	sleep with mattress topper during overnight diagnostic sleep study Receives: Device: Low rebound mattress toppers
High rebound mattress toppers	Experimental	sleep with mattress topper during overnight diagnostic sleep study Receives: Device: High rebound mattress toppers

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Sleep Time
Measured: 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.
Measured: Overnight study visit (up to approximately 10hrs)
Sleep Latency Assessed by PSG
The amount of time from lights off to falling asleep.
Measured: 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.
Measured: Overnight study visit (up to approximately 10hrs)
Percentage of Time in Bed During Each Sleep Stage
Measured: Overnight study visit (up to approximately 10hrs)
Position Changes Assessed by PSG
Number of times participant changed position during the sleep recording.
Measured: 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.
Measured: Overnight study visit (up to approximately 10hrs)
Heart Rate
Measured: 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
Measured: 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
Measured: Overnight study visit (up to approximately 10hrs)

Secondary outcomes (5)

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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Overnight study visit (up to approximately 10hrs)
Alliance Sleep Questionnaire (ASQ)
self-reported information related to sleep
Measured: Overnight study visit (up to approximately 10hrs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201519 Oct 2019

First posted16 Feb 2017
Study startOct 2015
Primary completion19 Oct 2019
Study completion19 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep DisordersStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 558 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03055156
Sponsor's protocol ID: IRB-34797
Status last verified: Oct 2020
First submitted: 26 Aug 2015
Last updated: 6 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
ClinicalTrials.gov ID: NCT03055156
Acronym / sponsor ID: IRB-34797
Conditions: Sleep Disorders
Keywords: Sleep Apnea, Insomnia, sleep disorders, sleep environment, core body temperature
Study type: Interventional
Recruitment status: Completed
Enrolment: 558 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Airweave Pte Ltd.
Study start: Oct 2015
Primary completion: 19 Oct 2019 (actual)
Study completion: 19 Oct 2019 (actual)
First posted: 16 Feb 2017 (actual)
Results: Posted 6 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e., airweave®) on sleep and sleep-related symptoms.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Low rebound mattress toppers	Experimental	Device: Low rebound mattress topperssleep with mattress topper during overnight diagnostic sleep study
High rebound mattress toppers	Experimental	Device: High rebound mattress topperssleep with mattress topper during overnight diagnostic sleep study

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (3 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low rebound mattress toppersAlso: TEMPUR-Topper SupremePatients will sleep on this mattress topper during their diagnostic sleep study.	Device	Low rebound mattress toppers
High rebound mattress toppersAlso: airweave® mattress topperPatients will sleep on this mattress topper during their diagnostic sleep study.	Device	High rebound mattress toppers

Primary outcome

Total Sleep Time
Time frame: Overnight study visit (up to approximately 10hrs)
Sleep Efficiency Assessed by Polysomnography (PSG)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Overnight study visit (up to approximately 10hrs)
Position Changes Assessed by PSG
Time frame: Overnight study visit (up to approximately 10hrs)
Number of times participant changed position during the sleep recording.
Apnea Hypopnea Index Assessed by PSG
Time frame: Overnight study visit (up to approximately 10hrs)
The number of apneas or hypopneas recorded during the study per hour of sleep.
Heart Rate
Time frame: Overnight study visit (up to approximately 10hrs)
Periodic Leg Movements (PLM) During Sleep
Time frame: 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
Time frame: Overnight study visit (up to approximately 10hrs)
EEG data collected from the electrode in position C2

5 secondary outcomes

Core Body Temperature
Time frame: Overnight study visit (up to approximately 10hrs)
Visual Analog Scale of Sleep
Time frame: Overnight study visit (up to approximately 10hrs)
Visual Analog Scale of Performance
Time frame: Overnight study visit (up to approximately 10hrs)
Visual Analog Scale of Mood
Time frame: Overnight study visit (up to approximately 10hrs)
Alliance Sleep Questionnaire (ASQ)
Time frame: Overnight study visit (up to approximately 10hrs)

Results and safety

Results posted to the registry on 6 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Rebound Mattress Toppers	281	281
High Rebound Mattress Toppers	273	273

Primary outcome: Total Sleep Time

Time frame: Overnight study visit (up to approximately 10hrs). Mean (Standard Deviation). Unit: hours

Measure	Low Rebound Mattress Toppers n = 216	High Rebound Mattress Toppers n = 200
Value	6.62 (1.25)	6.55 (1.59)

Low Rebound Mattress Toppers vs High Rebound Mattress Toppers: p = 0.60, t-test, 2 sided

Population analysed: 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.

Primary outcome: Sleep Efficiency Assessed by Polysomnography (PSG)

Time frame: Overnight study visit (up to approximately 10hrs). Mean (Standard Deviation). Unit: percentage time in bed asleep

Measure	Low Rebound Mattress Toppers n = 216	High Rebound Mattress Toppers n = 200
Value	82.87 (11.34)	79.73 (14.94)

Low Rebound Mattress Toppers vs High Rebound Mattress Toppers: p = 0.02, t-test, 2 sided

Population analysed: 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.

Primary outcome: Sleep Latency Assessed by PSG

Time frame: Overnight study visit (up to approximately 10hrs). Mean (Standard Deviation). Unit: minutes

Measure	Low Rebound Mattress Toppers n = 214	High Rebound Mattress Toppers n = 199
Value	18.67 (21.00)	24.05 (25.31)

Low Rebound Mattress Toppers vs High Rebound Mattress Toppers: p = 0.02, t-test, 2 sided

Population analysed: 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.

Primary outcome: Wake After Sleep Onset (WASO) Assessed by PSG

Time frame: Overnight study visit (up to approximately 10hrs). Mean (Standard Deviation). Unit: minutes

Measure	Low Rebound Mattress Toppers n = 215	High Rebound Mattress Toppers n = 199
Value	60.09 (43.57)	74.36 (67.55)

Low Rebound Mattress Toppers vs High Rebound Mattress Toppers: p = 0.01, t-test, 2 sided

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study visit overnight (up to 24hrs). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Rebound Mattress Toppers	0 of 281 (0%)	0 of 281 (0%)	0 of 281
High Rebound Mattress Toppers	0 of 273 (0%)	0 of 273 (0%)	0 of 273

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seiji Nishino, MD, PhD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low rebound mattress toppers and High rebound mattress toppers in people with Sleep Disorders, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Sleep Time (time frame: Overnight study visit (up to approximately 10hrs)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03055156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.