Pilot Study of cNEP for the Treatment of Snoring

Not Applicable

Terminated

• Conditions: Snoring
• Interventions: Device: continuous negative external pressure (cNEP)

• Registration Number: NCT02767843
• Lead Sponsor: Sommetrics, Inc.

Brief Summary

This pilot study will examine the efficacy and safety of continuous negative external pressure ("cNEP") for the treatment of chronic snoring in people without obstructive sleep apnea.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Results First Submitted: 2017-01-09
• Results First Submitted QC: 2017-03-20
• Results First Posted: 2017-03-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• sleep test within the previous six months that shows snoring of at least 30 dB for at least 30% of total sleep time
• AHI < 10/hr

Exclusion Criteria

• previous neck surgery or radiation
• carotid artery disease
• serious medical or psychiatric illness
• pregnancy
• silicone allergy
• excessive use of alcohol or sedating drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	continuous negative external pressure (cNEP)	continuous negative external pressure (cNEP) at various negative pressures

Primary Outcome Measures

Name	Time	Method
Adverse Events	one night	all adverse events
Response	one night	snoring decreased by \<50% from baseline

Secondary Outcome Measures

Name	Time	Method
Complete Response	one night	snoring for \< 5% of total sleep tim

Trial Locations

Locations (1)

California Center for Sleep Disorders; 🇺🇸 Alameda, California, United States