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

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ClinicalTrials.gov Identifier: NCT03055156
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : November 6, 2020
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
AIRWEAVE PTE. LTD.
Information provided by (Responsible Party):
Seiji Nishino, Stanford University

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.


Condition or disease Intervention/treatment Phase
Sleep Disorders Device: Low rebound mattress toppers Device: High rebound mattress toppers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
Study Start Date : October 2015
Actual Primary Completion Date : October 19, 2019
Actual Study Completion Date : October 19, 2019

Arm Intervention/treatment
Experimental: Low rebound mattress toppers
sleep with mattress topper during overnight diagnostic sleep study
Device: Low rebound mattress toppers
Patients will sleep on this mattress topper during their diagnostic sleep study.
Other Name: TEMPUR-Topper Supreme

Experimental: High rebound mattress toppers
sleep with mattress topper during overnight diagnostic sleep study
Device: High rebound mattress toppers
Patients will sleep on this mattress topper during their diagnostic sleep study.
Other Name: airweave® mattress topper




Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: Overnight study visit (up to approximately 10hrs) ]
  2. 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.

  3. Sleep Latency Assessed by PSG [ Time Frame: Overnight study visit (up to approximately 10hrs) ]
    The amount of time from lights off to falling asleep.

  4. 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.

  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 [ Time Frame: Overnight study visit (up to approximately 10hrs) ]
    Number of times participant changed position during the sleep recording.

  7. 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.

  8. Heart Rate [ Time Frame: Overnight study visit (up to approximately 10hrs) ]
  9. 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

  10. 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


Secondary Outcome Measures :
  1. Core Body Temperature [ Time Frame: 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.

  2. Visual Analog Scale of Sleep [ Time Frame: 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).

  3. Visual Analog Scale of Performance [ Time Frame: 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).

  4. Visual Analog Scale of Mood [ Time Frame: 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).

  5. Alliance Sleep Questionnaire (ASQ) [ Time Frame: Overnight study visit (up to approximately 10hrs) ]
    self-reported information related to sleep



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055156


Locations
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United States, California
Stanford Sleep Research Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
AIRWEAVE PTE. LTD.
Investigators
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Principal Investigator: Seiji Nishino, MD, PhD Stanford University
  Study Documents (Full-Text)

Documents provided by Seiji Nishino, Stanford University:
Study Protocol  [PDF] August 4, 2015
Statistical Analysis Plan  [PDF] October 13, 2020

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Responsible Party: Seiji Nishino, Professor, Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03055156    
Other Study ID Numbers: IRB-34797
First Posted: February 16, 2017    Key Record Dates
Results First Posted: November 6, 2020
Last Update Posted: November 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Seiji Nishino, Stanford University:
Sleep Apnea
Insomnia
sleep disorders
sleep environment
core body temperature
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders