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

NCT03055156 | Completed Results FDA Device

• 1 other identifier: IRB-34797
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Keywords

Sleep Apnea; Insomnia; sleep disorders; sleep environment; core body temperature

Outcome Measures

Primary Outcomes (10)

• Total Sleep Time

  Overnight study visit (up to approximately 10hrs)

• Sleep Efficiency Assessed by Polysomnography (PSG)

  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.

  Overnight study visit (up to approximately 10hrs)

• Sleep Latency Assessed by PSG

  The amount of time from lights off to falling asleep.

  Overnight study visit (up to approximately 10hrs)

• Wake After Sleep Onset (WASO) Assessed by PSG

  Total amount of minutes awake after the first sleep epoch.

  Overnight study visit (up to approximately 10hrs)

• Percentage of Time in Bed During Each Sleep Stage

  Overnight study visit (up to approximately 10hrs)

• Position Changes Assessed by PSG

  Number of times participant changed position during the sleep recording.

  Overnight study visit (up to approximately 10hrs)

• Apnea Hypopnea Index Assessed by PSG

  The number of apneas or hypopneas recorded during the study per hour of sleep.

  Overnight study visit (up to approximately 10hrs)

• Heart Rate

  Overnight study visit (up to approximately 10hrs)

• Periodic Leg Movements (PLM) During Sleep

  Number of times participant had periodic leg movements during the sleep recording

  Overnight study visit (up to approximately 10hrs)

• Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off

  EEG data collected from the electrode in position C2

  Overnight study visit (up to approximately 10hrs)

Secondary Outcomes (5)

• Core Body Temperature

  Overnight study visit (up to approximately 10hrs)

• Visual Analog Scale of Sleep

  Overnight study visit (up to approximately 10hrs)

• Visual Analog Scale of Performance

  Overnight study visit (up to approximately 10hrs)

• Visual Analog Scale of Mood

  Overnight study visit (up to approximately 10hrs)

• Alliance Sleep Questionnaire (ASQ)

  Overnight study visit (up to approximately 10hrs)

Study Arms (2)

Low rebound mattress toppers

EXPERIMENTAL

sleep with mattress topper during overnight diagnostic sleep study

Device: Low rebound mattress toppers

High rebound mattress toppers

EXPERIMENTAL

sleep with mattress topper during overnight diagnostic sleep study

Device: High rebound mattress toppers

Interventions

Low rebound mattress toppers DEVICE

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

Also known as: TEMPUR-Topper Supreme

Low rebound mattress toppers

High rebound mattress toppers DEVICE

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

Also known as: airweave® mattress topper

High rebound mattress toppers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead
• Airweave Pte Ltd.: collaborator

Study Sites (1)

Stanford Sleep Research Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Seiji Nishino
• Organization: Stanford University

nishino@stanford.edu

650-725-8602

Study Officials

• Seiji Nishino, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences, Stanford University School of Medicine

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: February 16, 2017
• Study Start: October 1, 2015
• Primary Completion: October 19, 2019
• Study Completion: October 19, 2019
• Last Updated: November 6, 2020
• Results First Posted: November 6, 2020

Record last verified: 2020-10

Locations

US (1)