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

Somne

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: vNEP

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04718142

20193101

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

vNEP with various shapes and sizes and overnight PSG

Experimental group

Description:

Administer vNEP therapy to study participants on the throat's anterior surface with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O. Assess participants for a reduction in Apnea-Hypopnea Index (AHI) for at least 120 minutes using polysomnography (PSG) and treatment tolerance compared to CPAP.

Treatment:

Device: vNEP