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

• ClinicalTrials.gov Identifier: NCT04718142
• Recruitment Status: Completed
• First Posted: January 22, 2021
• Last Update Posted: April 2, 2021
• Sponsor: Somne, LLC
• Collaborator: California Center for Sleep Disorders
• Information provided by (Responsible Party): Somne, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Device: vNEP	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 19, 2020
• Actual Primary Completion Date: March 15, 2021
• Actual Study Completion Date: March 30, 2021

Arms and Interventions

Arm	Intervention/treatment
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; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. No response [ Time Frame: For 120 min ]
   Did not achieve Primary Outcome Measure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

California Center for Sleep Disorders

San Leandro, California, United States, 94578

Sponsors and Collaborators

Somne, LLC

California Center for Sleep Disorders

Investigators

• Principal Investigator: Jerrold Kram, MD; California Center for Sleep Disorders

More Information

Additional Information:

Tanahashi, T., Nagano, J., Yamaguchi, Y. et al. Factors that predict adherence to continuous positive airway pressure treatment in obstructive sleep apnea patients: A prospective study in Japan. Sleep Biol. Rhythms 10, 126-135 (2012). 

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 

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Somne, LLC
• ClinicalTrials.gov Identifier: NCT04718142
• Other Study ID Numbers: 20193101
• First Posted: January 22, 2021
• Last Update Posted: April 2, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Somne, LLC:

negative pressure; variable negative external pressure

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases