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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: cNEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cNEP<br>cNEP treatment | Device: cNEP<br>* subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas<br>* Other names: continuous negative external pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of sustained responders | reduction of AHI of >50% and to <15/hr from qualifying PSG | two weeks after initiation of treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ethnic Japanese