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

NCT ID: NCT04718142

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2021-03-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

vNEP

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

California Center for Sleep Disorders

UNKNOWN

Sponsor Role: collaborator

Somne, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerrold Kram, MD

Role: PRINCIPAL_INVESTIGATOR

California Center for Sleep Disorders

Locations

California Center for Sleep Disorders

San Leandro, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 34596039 (View on PubMed)

Related Links

http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2011&index=18&absnum=7646

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

Other Identifiers

20193101

Identifier Type: -

Identifier Source: org_study_id