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

Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055156
• Other study ID #: IRB-34797
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 19, 2019

Study information

• Verified date: October 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: October 19, 2019
• Est. primary completion date: October 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Device:
• Low rebound mattress toppers
Patients will sleep on this mattress topper during their diagnostic sleep study.
• High rebound mattress toppers
Patients will sleep on this mattress topper during their diagnostic sleep study.

Locations

Country	Name	City	State
United States	Stanford Sleep Research Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	AIRWEAVE PTE. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time		Overnight study visit (up to approximately 10hrs)
Primary	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)
Primary	Sleep Latency Assessed by PSG	The amount of time from lights off to falling asleep.	Overnight study visit (up to approximately 10hrs)
Primary	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)
Primary	Percentage of Time in Bed During Each Sleep Stage		Overnight study visit (up to approximately 10hrs)
Primary	Position Changes Assessed by PSG	Number of times participant changed position during the sleep recording.	Overnight study visit (up to approximately 10hrs)
Primary	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)
Primary	Heart Rate		Overnight study visit (up to approximately 10hrs)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Alliance Sleep Questionnaire (ASQ)	self-reported information related to sleep	Overnight study visit (up to approximately 10hrs)