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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorders
• Intervention / Treatment: Device: Low rebound mattress toppers; Device: High rebound mattress toppers

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Sleep Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: airweave® mattress topper

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Body Temperature	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.	Overnight study visit (up to approximately 10hrs)
Visual Analog Scale of Sleep	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).	Overnight study visit (up to approximately 10hrs)
Visual Analog Scale of Performance	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).	Overnight study visit (up to approximately 10hrs)
Visual Analog Scale of Mood	visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good).	Overnight study visit (up to approximately 10hrs)
Alliance Sleep Questionnaire (ASQ)	self-reported information related to sleep	Overnight study visit (up to approximately 10hrs)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 19, 2019
• Study Completion (Actual): October 19, 2019

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Sleep Apnea; Insomnia; sleep disorders; core body temperature; sleep environment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: IRB-34797

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes