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

Sommetrics, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Obstructive Sleep Apnea

Interventions

continuous negative external pressureDEVICE

continuous negative external pressure will be applied to the anterior neck at night

Eligibility

Sex: ALLMin age: 22 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

California Center for Sleep Disorders

Alameda, California, United States

Outcomes

Primary Outcomes

Reduction in baseline apnea hypopnea index from baseline

Reduction in apnea hypopnea index (AHI) from the baseline value of \>50% and also \<15/hr

Time frame: End of Week 2 of home use

Secondary Outcomes

Collection of adverse events

Time frame: two week study period

Apnea hypopnea index, as measured by home sleep testing

Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012

Time frame: two weeks

Data from ClinicalTrials.gov

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