cNEP for the Treatment of Obstructive Sleep Apnea

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

Official Title
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Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: cNEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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>Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks | Device: cNEP<br>* continuous negative external pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | three weeks | 
| time of SpO2 (oxygen saturation) < 90% | the number of minutes during the overnight PSG when SpO2 is < 90% with cNEP in place | 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 | 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. | three weeks after the initiation of home cNEP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, sleep apnea, OSA, cNEP, continuous negative external pressure