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project progression decision was able to be made with the data already gathered
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This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FPH Device with SensAwake On + Pressure Support A | Active Comparator | FPH Device with SensAwake On + Pressure Support A |
|
| FPH Device with SensAwake Off + Pressure Support A | Active Comparator | FPH Device with SensAwake Off + Pressure Support A |
|
| FPH Device with SensAwake On + Pressure Support B | Active Comparator | FPH Device with SensAwake On + Pressure Support B |
|
| FPH Device with SensAwake Off + Pressure Support B | Active Comparator | FPH Device with SensAwake Off + Pressure Support B |
|
| Competitor's PAP Released Device + Pressure Support A | Active Comparator | Competitor's PAP Released Device + Pressure Support A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FPH Device with SensAwake On + Pressure Support A | Device | FPH Device with SensAwake On + Pressure Support A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI) | Through the device and independent flow logger | 3 nights |
| Apnea Hypopnea Index (AHI) | Through the polysomnography | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Comfort | Through a subjective questionnaire | 3 nights |
| Compliance | Through the device and independent flow logger | 3 nights |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare | Auckland | 0600 | New Zealand | |||
| WellSleep Centre |
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| Competitor's PAP Released Device + Pressure Support B |
| Active Comparator |
Competitor's PAP Released Device + Pressure Support B |
|
| FPH Device with SensAwake Off + Pressure Support A | Device | FPH Device with SensAwake Off + Pressure Support A |
|
| FPH Device with SensAwake On + Pressure Support B | Device | FPH Device with SensAwake On + Pressure Support B |
|
| FPH Device with SensAwake Off + Pressure Support B | Device | FPH Device with SensAwake Off + Pressure Support B |
|
| Competitor's PAP Released Device + Pressure Support A | Device | Competitor's PAP Released Device + Pressure Support A |
|
| Competitor's PAP Released Device + Pressure Support B | Device | Competitor's PAP Released Device + Pressure Support B |
|
| Device Triggering | Through the device | 3 nights |
| Device Triggering | Through the polysomnography | 1 night |
| Wellington |
| 6035 |
| New Zealand |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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