Clinical trial NCT03055156: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorders
Keywords: Sleep Apnea
Insomnia
sleep disorders
sleep environment
core body temperature
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Airweave Pte Ltd.
First posted: 2017-02-16
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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).

Primary outcomes:
measure: Total Sleep Time
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Sleep Efficiency Assessed by Polysomnography (PSG)
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Sleep Latency Assessed by PSG
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Wake After Sleep Onset (WASO) Assessed by PSG
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Percentage of Time in Bed During Each Sleep Stage
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Position Changes Assessed by PSG
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Apnea Hypopnea Index Assessed by PSG
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Heart Rate
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Periodic Leg Movements (PLM) During Sleep
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
timeFrame: Overnight study visit (up to approximately 10hrs)
Secondary outcomes:
measure: Core Body Temperature
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Visual Analog Scale of Sleep
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Visual Analog Scale of Performance
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Visual Analog Scale of Mood
timeFrame: Overnight study visit (up to approximately 10hrs)
measure: Alliance Sleep Questionnaire (ASQ)
timeFrame: Overnight study visit (up to approximately 10hrs)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Sleep Research Center
state: California
Study officials:
affiliation: Stanford University
name: Seiji Nishino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: