N/A
Completed N=554
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
Source: ClinicalTrials.gov NCT03055156 ↗Enrolled (actual)
554
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Total Sleep Time — 6.62; 6.55 hours — p=0.60
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time |
6.62; 6.55 | 0.60 |
| PRIMARY Sleep Efficiency Assessed by Polysomnography (PSG) |
82.87; 79.73 | 0.02 sig |
| PRIMARY Sleep Latency Assessed by PSG |
18.67; 24.05 | 0.02 sig |
| PRIMARY Wake After Sleep Onset (WASO) Assessed by PSG |
60.09; 74.36 | 0.01 sig |
| PRIMARY Percentage of Time in Bed During Each Sleep Stage |
17.11; 20.16; 16.26; 14.92; 6.36; 6.46 | 0.02 sig |
| PRIMARY Position Changes Assessed by PSG |
14.64; 15.65 | 0.38 |
| PRIMARY Apnea Hypopnea Index Assessed by PSG |
34.15; 33.86 | 0.96 |
| PRIMARY Heart Rate |
61.24; 64.82 | — |
| PRIMARY Periodic Leg Movements (PLM) During Sleep |
99.56; 91.51 | 0.55 |
| PRIMARY Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off |
31.34; 31.93; 28.61; 32.00; 24.19; 27.02 | 0.86 |
| SECONDARY Core Body Temperature |
36.42; 36.29; 36.49; 36.52; 36.46; 36.49 | 0.389 |
| SECONDARY Visual Analog Scale of Sleep |
4.93; 4.80 | 0.61 |
| SECONDARY Visual Analog Scale of Performance |
5.54; 5.45 | 0.71 |
| SECONDARY Visual Analog Scale of Mood |
6.60; 6.60 | 1.00 |
| SECONDARY Alliance Sleep Questionnaire (ASQ) |
— | — |
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).
Data sourced from ClinicalTrials.gov (NCT03055156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.