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

NCT ID: NCT03055156

Last Updated: 2020-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disorders

Keywords

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Sleep Apnea Insomnia sleep disorders sleep environment core body temperature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Low rebound mattress toppers

sleep with mattress topper during overnight diagnostic sleep study

Group Type EXPERIMENTAL

Low rebound mattress toppers

Intervention Type DEVICE

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

High rebound mattress toppers

sleep with mattress topper during overnight diagnostic sleep study

Group Type EXPERIMENTAL

High rebound mattress toppers

Intervention Type DEVICE

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

Interventions

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Low rebound mattress toppers

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

Intervention Type DEVICE

High rebound mattress toppers

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

Intervention Type DEVICE

Other Intervention Names

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TEMPUR-Topper Supreme airweave® mattress topper

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Airweave Pte Ltd.

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Seiji Nishino

Professor, Psychiatry and Behavioral Sciences, Stanford University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seiji Nishino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Sleep Research Center

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IRB-34797

Identifier Type: -

Identifier Source: org_study_id