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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 : Enrolling by invitation
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 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. Sleep efficiency assessed by polysomnography (PSG) [ Time Frame: 1 night ]
  2. Sleep latency assessed by PSG [ Time Frame: 1 night ]
  3. Wake after sleep onset (WASO) assessed by PSG [ Time Frame: 1 night ]
  4. Apnea hypopnea index assessed by PSG [ Time Frame: 1 night ]
  5. Periodic leg movements assessed by PSG [ Time Frame: 1night ]
  6. Position changes assessed by PSG [ Time Frame: 1 night ]

Secondary Outcome Measures :
  1. Core body temperature [ Time Frame: 1 night ]
    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 scales [ Time Frame: 1 night ]
    subjective evaluation of sleep and sleep-related symptoms

  3. Alliance Sleep Questionnaire (ASQ) [ Time Frame: 1 night ]
    self-reported information related to sleep



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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 undergoing a positive airway pressure titration or a split night study.
  • 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


Sponsors and Collaborators
Stanford University
AIRWEAVE PTE. LTD.
Investigators
Principal Investigator: Seiji Nishino, MD, PhD Stanford University

Responsible Party: Seiji Nishino, Professor, Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03055156     History of Changes
Other Study ID Numbers: IRB-34797
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: October 2016

Keywords provided by Seiji Nishino, Stanford University:
Sleep Apnea
Insomnia
sleep disorders
sleep environment
core body temperature

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders