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Completed

NCT Number: NCT03055156

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

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.

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Key information

Conditions

Sleep Disorders Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Sleep Research Center

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low rebound mattress toppers

Device

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

Other names: TEMPUR-Topper Supreme

High rebound mattress toppers

Device

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

Other names: airweave® mattress topper

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Airweave Pte Ltd.

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 16, 2017
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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