Back to resultsEffect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
Primary Purpose
Sleep Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low rebound mattress toppers
High rebound mattress toppers
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Disorders focused on measuring Sleep Apnea, Insomnia, sleep disorders, sleep environment, core body temperature
Eligibility Criteria
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).
Sites / Locations
- Stanford Sleep Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low rebound mattress toppers
High rebound mattress toppers
Arm Description
sleep with mattress topper during overnight diagnostic sleep study
sleep with mattress topper during overnight diagnostic sleep study
Outcomes
Primary Outcome Measures
Total Sleep Time
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.
Sleep Latency Assessed by PSG
The amount of time from lights off to falling asleep.
Wake After Sleep Onset (WASO) Assessed by PSG
Total amount of minutes awake after the first sleep epoch.
Percentage of Time in Bed During Each Sleep Stage
Position Changes Assessed by PSG
Number of times participant changed position during the sleep recording.
Apnea Hypopnea Index Assessed by PSG
The number of apneas or hypopneas recorded during the study per hour of sleep.
Heart Rate
Periodic Leg Movements (PLM) During Sleep
Number of times participant had periodic leg movements during the sleep recording
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
Secondary Outcome Measures
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.
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).
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).
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).
Alliance Sleep Questionnaire (ASQ)
self-reported information related to sleep
Full Information
NCT ID
NCT03055156
First Posted
August 26, 2015
Last Updated
October 15, 2020
Sponsor
Stanford University
Collaborators
AIRWEAVE PTE. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03055156
Brief Title
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
Official Title
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 19, 2019 (Actual)
Study Completion Date
October 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
AIRWEAVE PTE. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders
Keywords
Sleep Apnea, Insomnia, sleep disorders, sleep environment, core body temperature
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
558 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low rebound mattress toppers
Arm Type
Experimental
Arm Description
sleep with mattress topper during overnight diagnostic sleep study
Arm Title
High rebound mattress toppers
Arm Type
Experimental
Arm Description
sleep with mattress topper during overnight diagnostic sleep study
Intervention Type
Device
Intervention Name(s)
Low rebound mattress toppers
Other Intervention Name(s)
TEMPUR-Topper Supreme
Intervention Description
Patients will sleep on this mattress topper during their diagnostic sleep study.
Intervention Type
Device
Intervention Name(s)
High rebound mattress toppers
Other Intervention Name(s)
airweave® mattress topper
Intervention Description
Patients will sleep on this mattress topper during their diagnostic sleep study.
Primary Outcome Measure Information:
Title
Total Sleep Time
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Sleep Efficiency Assessed by Polysomnography (PSG)
Description
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.
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Sleep Latency Assessed by PSG
Description
The amount of time from lights off to falling asleep.
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Wake After Sleep Onset (WASO) Assessed by PSG
Description
Total amount of minutes awake after the first sleep epoch.
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Percentage of Time in Bed During Each Sleep Stage
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Position Changes Assessed by PSG
Description
Number of times participant changed position during the sleep recording.
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Apnea Hypopnea Index Assessed by PSG
Description
The number of apneas or hypopneas recorded during the study per hour of sleep.
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Heart Rate
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Periodic Leg Movements (PLM) During Sleep
Description
Number of times participant had periodic leg movements during the sleep recording
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
Description
EEG data collected from the electrode in position C2
Time Frame
Overnight study visit (up to approximately 10hrs)
Secondary Outcome Measure Information:
Title
Core Body Temperature
Description
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.
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Visual Analog Scale of Sleep
Description
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).
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Visual Analog Scale of Performance
Description
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).
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Visual Analog Scale of Mood
Description
visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good).
Time Frame
Overnight study visit (up to approximately 10hrs)
Title
Alliance Sleep Questionnaire (ASQ)
Description
self-reported information related to sleep
Time Frame
Overnight study visit (up to approximately 10hrs)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seiji Nishino, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Sleep Research Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
We'll reach out to this number within 24 hrs