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The goal of this study is to evaluate the effectiveness of the Elara APAP device.
A prospective open label study to assess the efficacy of the Elara APAP device when used in patients with obstructive sleep apnea. Subjects will sign Informed Consent and undergo screening/baseline and a 1 night in-lab PSG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Sleepnet Elara Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleepnet Elara Treatment | Device | Subject to have a 1 night in-lab PSG |
|
| Measure | Description | Time Frame |
|---|---|---|
| AHI 4% | The primary endpoint of this study is treatment night AHI 4%. A subject is considered a success if the Apnea Hypopnea Index calculated by using hypopneas that cause a 4% or greater drop in blood oxygen levels per hour of sleep (AHI4) measured during the 1-night treatment study (PSG) is less than 10 events/hour or less than 10% of the baseline AHI4 value determined at previous diagnosis, whichever is greater. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Brown, M.S. | Contact | 408-881-2611 | abrown@abioclinical.com |
| Name | Affiliation | Role |
|---|---|---|
| Anthony McLeod, MD | University Sleep Disorders Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Sleep Disorders Center | Auburn | Alabama | 36832 | United States |
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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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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |