Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea

Not Applicable

Completed

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

• Registration Number: NCT03375905
• Lead Sponsor: Sommetrics, Inc.

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Primary Completion: 2019-03-28
• Study Completion: 2019-04-26
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• both parents ethnically Japanese, or one parent Japanese and the other east-Asian
• PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and <80% of apneas and hypopneas are obstructive
• cNEP collar fits and is well-tolerated

Key exclusion Criteria:

• BMI >34
• abnormalities in neck structure
• sleep disturbance other than obstructive sleep apnea
• serious medical illness
• pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cNEP	cNEP	cNEP treatment

Primary Outcome Measures

Name	Time	Method
proportion of sustained responders	two weeks after initiation of treatment	reduction of AHI of \>50% and to \<15/hr from qualifying PSG

Secondary Outcome Measures

Name	Time	Method
CGI of satisfaction with the cNEP device	after two weeks of treatment	clinical global impressions of the cNEP device
proportion of initial responders	at PSG 1, one day	reduction of AHI of \>50% and to \<15/hr from qualifying PSG
ODI comparison with qualifying PSG	one day, on three separate study occasions	oxygen desaturation index
AHI comparison with qualifying PSG	one day, on three separate study occasions	apnea-hypopnea index
SpO2 <90% comparison with qualifying PSG	one day, on three separate study occasions	oxygen desaturation index \<90%
CGI of sleep	three months, and two weeks, respectively	clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment
Treatment-emergent adverse events	two weeks	tabulation of treatment-emergent adverse events

Trial Locations

Locations (1)

The Sleep Lab; 🇺🇸 Kaneohe, Hawaii, United States