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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cNEP | Experimental | Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cNEP | Device | continuous negative external pressure |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Blackman, MD | Toronto Sleep Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Sleep Institute | Toronto | Ontario | M4P 1P2 | Canada |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |