cNEP for the Treatment of Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: cNEP

• Registration Number: NCT02677168
• Lead Sponsor: Sommetrics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-09
• Study Start: 2016-05
• Status Verified: 2017-10
• Primary Completion: 2017-11-03
• Study Completion: 2017-11-03
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cNEP	cNEP	Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks

Primary Outcome Measures

Name	Time	Method
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II	three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I	A response (either initial or sustained) is defined as an AHI that is \< 50% of the qualifying PSG (polysomnography) that is also \< 15/hr
occurrence of adverse events	three weeks	Adverse events that occur during the three weeks of cNEP home use.

Secondary Outcome Measures

Name	Time	Method
"Initial Response" of AHI at PSG I	up to 12 months after the qualifying PSG	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 of SpO2 (oxygen saturation) < 90%	during each of the overnight PSGs	the number of minutes during the overnight PSG when SpO2 is \< 90% with cNEP in place
Three CGI (clinical global impression) subjective measures	three weeks after the initiation of home cNEP	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.
Comparison of AHI at PSG I and PSG II	three weeks	The AHI determined at PSG II will be compared with that of PSG I
hours of home use of cNEP per night	three weeks after initiation of home cNEP	the number of hours of each night at home that the subject uses cNEP

Trial Locations

Locations (1)

Toronto Sleep Institute; 🇨🇦 Toronto, Ontario, Canada