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| Name | Class |
|---|---|
| Ventus Medical, Inc. | INDUSTRY |
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The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provent | Device | This is a non-randomized, single-arm, case series study. All subjects will receive Provent device. |
| Measure | Description | Time Frame |
|---|---|---|
| Week 1 AHI as compared to Screening/Baseline AHI | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Week 5 AHI as compared to Screening/Baseline AHI | 5 weeks | |
| Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline | 5 weeks | |
| Epworth Sleepiness Scale: Week 5 vs. Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James K Walsh, Ph.D. | Sleep Medicine and Research Center at St. Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Medicine and Research Center at St. Luke's Hospital | Chesterfield | Missouri | 63017 | 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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| 5 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |