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

Stanford University

Status: Completed

Conditions: Sleep Disorders

Treatments: Device: Low rebound mattress toppers; Device: High rebound mattress toppers

Study type: Interventional

Funder types: Other

Identifiers

NCT03055156

IRB-34797

Details and patient eligibility

About

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.

Enrollment: 558 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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558 participants in 2 patient groups

Low rebound mattress toppers

Experimental group

Description:

sleep with mattress topper during overnight diagnostic sleep study

Treatment:

Device: Low rebound mattress toppers

High rebound mattress toppers

Experimental group

Description:

sleep with mattress topper during overnight diagnostic sleep study

Treatment:

Device: High rebound mattress toppers