cNEP for the Treatment of Obstructive Sleep Apnea

Sommetrics, Inc.71 enrolled

Overview

The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Apnea, Obstructive

Interventions

cNEPDEVICE

continuous negative external pressure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG") * on that PSG, AHI must be 10 - 50/hr and \>80% of the apneas and hypopneas must be obstructive * no significant changes in health, medications, or lifestyle since the qualifying PSG Key Exclusion Criteria: * previous major surgery, injury or radiation to the neck * beard or excessive hair on the area of the neck where the collar will be applied * carotid artery disease * serious medical conditions * pregnancy * use of home oxygen * silicone allergy * sleep disturbance other than obstructive sleep apnea

Locations (1)

Toronto Sleep Institute

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II

A response (either initial or sustained) is defined as an AHI that is \< 50% of the qualifying PSG (polysomnography) that is also \< 15/hr

Time frame: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I

occurrence of adverse events

Adverse events that occur during the three weeks of cNEP home use.

Time frame: three weeks

Secondary Outcomes

"Initial Response" of AHI at PSG I

An AHI (apnea hypopnea index) that is \<50% of that of the qualifying PSG, and \<15/hr at PSG I, with cNEP in place.

Time frame: up to 12 months after the qualifying PSG

Comparison of AHI at PSG I and PSG II

The AHI determined at PSG II will be compared with that of PSG I

Time frame: three weeks

time of SpO2 (oxygen saturation) < 90%

the number of minutes during the overnight PSG when SpO2 is \< 90% with cNEP in place

Time frame: during each of the overnight PSGs

hours of home use of cNEP per night

the number of hours of each night at home that the subject uses cNEP

Time frame: three weeks after initiation of home cNEP

Three CGI (clinical global impression) subjective measures

Seven-item Likert CGI scales of three subjective measures: 1) subject's view of cNEP vs CPAP, 2) overall satisfaction with cNEP, 3) bed partner's feelings about cNEP.

Data from ClinicalTrials.gov

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