N/A
N=12
Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02250417 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Apnea-hypopnea Index (AHI)- Intention to Treat Analysis — 9.8; 12.6 events/hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wave sleep surface (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Index (AHI)- Intention to Treat Analysis |
9.8; 12.6 | — |
| SECONDARY Objective Sleep Quality |
379.8; 363.7; 424.1; 414.3; 38.8; 36.5 | — |
| SECONDARY Sleep Efficiency |
89.9; 87.9 | — |
Summary
Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA.
The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.
Eligibility Criteria
Inclusion Criteria
We will recruit subjects who are:
- 18 years of age and above
- Willing and able to give informed consent
- Prior sleep study done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care and performed no more than 12 months prior to enrollment that meets the following:
- overall AHI 5-30 events/hr
- at least 20 minutes of recorded sleep in the supine and nonsupine postures
- positional OSA defined as > 50% reduction in the AHI between the supine and nonsupine postures and AHI 16 or a prior history of falling asleep while driving
- Unstable medical problem such as uncontrolled hypertension.
- Body Mass Index (BMI) > 45 kg/m2
Data sourced from ClinicalTrials.gov (NCT02250417). 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.