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| ID | Type | Description | Link |
|---|---|---|---|
| ABF-2007-MCT-03 |
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The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy arm is significantly greater than that for all participants in the CPAP therapy arm.
Secondary Measures
The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include:
The hypothesis of this investigation is that the BiPAP® Auto with Bi-Flex® improves acceptance of and adherence to positive pressure therapy in participants who are newly diagnosed with OSA and who meet objective criteria for PAP failure during their initial encounter with CPAP in the sleep laboratory.
This hypothesis will be tested using a two-arm, randomized, double-blind design. Participants failing to tolerate CPAP therapy in the sleep laboratory during their titration night will be randomized to a BiPAP® Auto with Bi-Flex® titration or a CPAP titration night in the lab. Participants will then go home with their respective therapy for three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Auto M series device set to Bi Flex |
|
| 2 | Active Comparator | Set to standard CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPap auto with Fi Flex | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| ASdherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include: compliance, AHI, HRV, FOSQ, Visual Analog Scale for mask comfort & satisfaction, ESS, PVT, Attitudes toward use, Actigraphy & sleep diary, FSS, & DFS | 90 days |
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Inclusion Criterion:
Sub-optimal PSG titration: at least one of the following:
Exclusion Criterion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clayton Slep Institute | St Louis | Missouri | 63143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22334808 | Derived | Powell ED, Gay PC, Ojile JM, Litinski M, Malhotra A. A pilot study assessing adherence to auto-bilevel following a poor initial encounter with CPAP. J Clin Sleep Med. 2012 Feb 15;8(1):43-7. doi: 10.5664/jcsm.1658. |
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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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| Standard CPAP | Device | CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O) |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |