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CompletedNCT04718142Updated Apr 2, 2021

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

An interventional study of vNEP in Obstructive Sleep Apnea, sponsored by Somne, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Somne, LLC · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Mar 2021, 5 years 7 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • negative pressure
  • variable negative external pressure
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In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 28 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

This is the only study on the registry with Somne, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    vNEP with various shapes and sizes and overnight PSG

    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.

    Device: vNEP

Interventions

  • DevicevNEP

    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.

06

What researchers measure

Primary outcomes

  1. Complete response

    Decrease in AHI \<=5

    Time frame: For 120 min

  2. Response

    Decrease in AHI of \>=50% from baseline

    Time frame: For 120 min

Secondary outcomes

  1. No response

    Did not achieve Primary Outcome Measure

    Time frame: For 120 min

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Study locations

1 site
  • California Center for Sleep Disorders
    San Leandro, California 94578, United States
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References and documents

Publications

  • Lee SA, Amis TC, Byth K, Larcos G, Kairaitis K, Robinson TD, Wheatley JR. Heavy snoring as a cause of carotid artery atherosclerosis. Sleep. 2008 Sep;31(9):1207-13. PubMed 18788645 ↗
  • Friedman M, Shnowske K, Hamilton C, Samuelson CG, Hirsch M, Pott TR, Yalamanchali S. Mandibular advancement for obstructive sleep apnea: relating outcomes to anatomy. JAMA Otolaryngol Head Neck Surg. 2014 Jan;140(1):46-51. doi: 10.1001/jamaoto.2013.5746. PubMed 24263288 ↗
  • Gelardi M, Del Giudice AM, Cariti F, Cassano M, Farras AC, Fiorella ML, Cassano P. Acoustic pharyngometry: clinical and instrumental correlations in sleep disorders. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):257-65. doi: 10.1016/s1808-8694(15)31075-2. PubMed 17589736 ↗
  • Kais SS, Klein KB, Rose RM, Endemann S, Coyle WJ. Continuous negative external pressure (cNEP) reduces respiratory impairment during screening colonoscopy: a pilot study. Endoscopy. 2016 Jun;48(6):584-7. doi: 10.1055/s-0042-102533. Epub 2016 Apr 25. PubMed 27110692 ↗
  • Kendzerska T, Grewal M, Ryan CM. Utility of Acoustic Pharyngometry for the Diagnosis of Obstructive Sleep Apnea. Ann Am Thorac Soc. 2016 Nov;13(11):2019-2026. doi: 10.1513/AnnalsATS.201601-056OC. PubMed 27529798 ↗
  • Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704. PubMed 8464434 ↗
  • 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. PubMed 34596039 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04718142
Lead sponsor
Somne, LLC
Collaborators
California Center for Sleep Disorders
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
Oct 19, 2020
Primary completion
Mar 15, 2021
Completion
Mar 30, 2021
Last update
Apr 2, 2021

Study contacts

Jerrold Kram, MD
principal investigator · California Center for Sleep Disorders

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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