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no eligible subjects were available for recruitment
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This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cNEP | Experimental | continuous negative external pressure will be used nightly by all participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous negative external pressure | Device | continuous negative external pressure will be applied to the anterior neck at night |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in baseline apnea hypopnea index from baseline | Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr | End of Week 2 of home use |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of adverse events | Collection of adverse events | two week study period |
| Apnea hypopnea index, as measured by home sleep testing | Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical global impression of cNEP experience | Assessment of the tolerability of cNEP to the subject via a clinical global impression scale | end of week two of home use |
| Bed partner's views of cNEP via a clinical global impression scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrold Kram, MD | California Center for Sleep Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Center for Sleep Disorders | Alameda | California | 94501 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| two weeks |
Determination of the bed partner's views of the subject using cNEP in the home setting using a clinical global impression scale
| end of two weeks of home use |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |