Status:
COMPLETED
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Lead Sponsor:
Somne, LLC
Collaborating Sponsors:
California Center for Sleep Disorders
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-65 years
Phase:
NA
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 encou...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04718142
Start Date
October 19 2020
End Date
March 30 2021
Last Update
April 2 2021
Active Locations (1)
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1
California Center for Sleep Disorders
San Leandro, California, United States, 94578