Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT04718142

Run by

Somne, LLC

People needed

28

Starts

2020-10-19

Expected to finish

2021-03-30

Last updated by the study team

2021-04-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

Where it is running

• California Center for Sleep Disorders — San Leandro, California, United States

Full record on ClinicalTrials.gov

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