Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 3

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
    

Detailed description: 
      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.
    

Intervention name(s): BiPap auto with Fi Flex; Standard CPAP
Intervention type(s): Device; Device
Intervention description(s): MinEPAP = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)
MaxIPAP = 25 cm H2O
MinPS = 2 cm H2O (cannot be adjusted)
MaxPS = 8 cm H2O
Bi-Flex setting of 3; CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: OSA