Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
Brief Summary: 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:

* Hours of use per night, for all nights
* Hours of use per night, for nights with therapy use
* Device derived AHI
* Heart Rate Variability
* Functional Outcomes of Sleep Questionnaire (FOSQ),
* 10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy,
* Epworth Sleepiness Scale (ESS) questionnaire
* Psychomotor Vigilance Task
* Attitudes toward use
* Actigraphy (sleep continuity) and sleep diary
* Fatigue Severity Scale
* Daytime Functioning Scale


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: constant CPAP devices | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Device: automatic CPAP devices | Intervention Type: DEVICE; Name: constant CPAP devices; Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: automatic CPAP devices; Assigned to Arm(s): 2
B: Arm Label: Auto Aflex; Type: ACTIVE_COMPARATOR; Interventions: Device: Auto AFlex | Arm Label: Auto CPAP; Type: ACTIVE_COMPARATOR; Interventions: Device: Auto CPAP | Arm Label: CPAP; Type: ACTIVE_COMPARATOR; Interventions: Device: CPAP | Intervention Type: DEVICE; Name: Auto AFlex; Assigned to Arm(s): Auto Aflex | Intervention Type: DEVICE; Name: Auto CPAP; Assigned to Arm(s): Auto CPAP | Intervention Type: DEVICE; Name: CPAP; Assigned to Arm(s): CPAP
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: BiPap auto with Fi Flex | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard CPAP | Intervention Type: DEVICE; Name: BiPap auto with Fi Flex; Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: Standard CPAP; Assigned to Arm(s): 2
D: Arm Label: Fixed pressure; Type: ACTIVE_COMPARATOR; Interventions: Device: S8 Spirit 2, Device: Somnosmart 2, Device: Remstar Auto | Arm Label: Auto-adjusting pressure; Type: ACTIVE_COMPARATOR; Interventions: Device: S8 Spirit 2, Device: Somnosmart 2, Device: Remstar Auto | Intervention Type: DEVICE; Name: S8 Spirit 2; Assigned to Arm(s): Auto-adjusting pressure, Fixed pressure | Intervention Type: DEVICE; Name: Somnosmart 2; Assigned to Arm(s): Auto-adjusting pressure, Fixed pressure | Intervention Type: DEVICE; Name: Remstar Auto; Assigned to Arm(s): Auto-adjusting pressure, Fixed pressure

Answer: C