Obstructive Sleep Apnea
Conditions
Keywords
negative pressure, variable negative external pressure
Brief summary
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an alternative therapy. This study assessed a variety of sizes and shapes of collars and a range of pressures for variable negative external pressure (vNEP) treatment in subjects having moderate OSA to identify combinations that improve the efficacy and comfort of this emerging therapy. Observations made in this study may be used to plan a more definitive follow-on investigation.
Interventions
DEVICEvNEP
Apply vNEP therapy to the anterior surface of the throat with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O and vNEP devices of varying shapes and sizes.
Sponsors
California Center for Sleep Disorders
Somne, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* a polysomnogram study or home sleep test within the previous six months that shows either an AHI \> 15 and AHI \<= 30 * able, in the opinion of the investigator, to understand and comply with all study procedures * the vNEP collar is determined by the investigator to properly fit the subject and is well-tolerated after application to the neck.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | For 120 min | Decrease in AHI \<=5 |
| Response | For 120 min | Decrease in AHI of \>=50% from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No response | For 120 min | Did not achieve Primary Outcome Measure |
Countries
United States
Outcome results
None listed