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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Center for Sleep Disorders

San Leandro, California, 94578, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vNEP

Device

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.

Primary outcomes

  1. Complete response

    Time frame: For 120 min

    Decrease in AHI <=5

  2. Response

    Time frame: For 120 min

    Decrease in AHI of >=50% from baseline

Secondary outcomes

  1. No response

    Time frame: For 120 min

    Did not achieve Primary Outcome Measure

Sponsors and collaborators

Lead sponsor

Somne, LLC

Industry

Collaborators

  • California Center for Sleep Disorders

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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