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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
28
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.
California Center for Sleep Disorders
San Leandro, California, United States
Complete response
Decrease in AHI \<=5
Time frame: For 120 min
Response
Decrease in AHI of \>=50% from baseline
Time frame: For 120 min
No response
Did not achieve Primary Outcome Measure
Time frame: For 120 min
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