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| Name | Class |
|---|---|
| Veranex, Inc. | UNKNOWN |
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To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto Night One, Manual Night Two | Active Comparator | Will undergo Automatic Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Manual EPAP during Non-Invasive Ventilation in PSG Night 2 |
|
| Manual Night One, Auto Night Two | Active Comparator | Will undergo Manual Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Auto-EPAP during Non-Invasive Ventilation in PSG Night 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive Ventilation | Device | Provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment. | The log of the subject's mean Oxygen Desaturation Index (ODI4%) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)). | Up to Five Weeks |
| Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment. | The log of the subject's mean Apnea Hypopnea Index (AHI) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)). | Up to Five Weeks |
| The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs). | Up to Five Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insomnia and Sleep Institute of Arizona, LLC | Scottsdale | Arizona | 85255 | United States | ||
| University of California San Diego |
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The study is a prospective, multicenter, single-blind, randomized, cross-over study design.
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Study subjects will be blinded to the sequence arm that they are randomized to. Investigators and site study staff will be unblinded. The scorer(s) of the polysomnography will be blinded to which therapy is being used for objective determination of the primary endpoint.
| San Diego |
| California |
| 92121 |
| United States |
| Delta Waves | Colorado Springs | Colorado | 80918 | United States |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | United States |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D010845 | Obesity Hypoventilation Syndrome |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009468 | Neuromuscular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D007040 | Hypoventilation |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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