Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: continuous negative external pressure

• Registration Number: NCT03108417
• Lead Sponsor: Sommetrics, Inc.

Brief Summary

This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-25
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• must have completed study SOM-012 and been categorized as a "responder"
• the subject agrees to participation by signing an informed consent statement

Exclusion Criteria

• medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cNEP	continuous negative external pressure	continuous negative external pressure will be used nightly by all participants

Primary Outcome Measures

Name	Time	Method
Reduction in baseline apnea hypopnea index from baseline	End of Week 2 of home use	Reduction in apnea hypopnea index (AHI) from the baseline value of \>50% and also \<15/hr

Secondary Outcome Measures

Name	Time	Method
Collection of adverse events	two week study period	Collection of adverse events
Apnea hypopnea index, as measured by home sleep testing	two weeks	Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012

Trial Locations

Locations (1)

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