Clinical trial NCT04718142: Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Official title: Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: negative pressure
variable negative external pressure
Lead sponsor: Somne, LLC
Sponsor class: INDUSTRY
Collaborators: name: California Center for Sleep Disorders
First posted: 2021-01-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complete response
timeFrame: For 120 min
measure: Response
timeFrame: For 120 min
Secondary outcomes:
measure: No response
timeFrame: For 120 min
Other outcomes:
Locations:
city: San Leandro
country: United States
facility: California Center for Sleep Disorders
state: California
Study officials:
affiliation: California Center for Sleep Disorders
name: Jerrold Kram, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Kram JA, Pelayo R. Variable negative external pressure-an alternative to continuous positive airway pressure for the treatment of obstructive sleep apnea: a pilot study. J Clin Sleep Med. 2022 Jan 1;18(1):305-314. doi: 10.5664/jcsm.9680.