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

NCT04718142 | Completed FDA Device

• 1 other identifier: 20193101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

negative pressure; variable negative external pressure

Outcome Measures

Primary Outcomes (2)

• Complete response

  Decrease in AHI \<=5

  For 120 min

• Response

  Decrease in AHI of \>=50% from baseline

  For 120 min

Secondary Outcomes (1)

• No response

  For 120 min

Study Arms (1)

vNEP with various shapes and sizes and overnight PSG

EXPERIMENTAL

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

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.

vNEP with various shapes and sizes and overnight PSG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Somne, LLC: lead
• California Center for Sleep Disorders: collaborator

Study Sites (1)

California Center for Sleep Disorders

San Leandro, California, 94578, United States

Location

Related Publications (7)

• 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.

  PMID: 18788645 BACKGROUND

• 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.

  PMID: 24263288 BACKGROUND

• 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.

  PMID: 17589736 BACKGROUND

• 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.

  PMID: 27110692 BACKGROUND

• 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.

  PMID: 27529798 BACKGROUND

• 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.

  PMID: 8464434 BACKGROUND

• 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.

  PMID: 34596039 DERIVED

Related Links

• Rose RM, Aarestad J, Flicker W et al. Effect of continuous negative external pressure (cNEP) on upper airway (UA) structure and function: implications for obstructive sleep apnea and anesthesia care. Presented at the annual meeting of the America Society

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jerrold Kram, MD

  California Center for Sleep Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: October 19, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 30, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)