Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP)
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

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 continuous
      positive airway pressure (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 (auto Bilevel) arm is significantly
      greater than that for all participants in the CPAP therapy arm
    

Detailed description: 
      Initial Screening

      It is preferred that participant's are recruited the morning after their failed clinical CPAP
      titration in the lab. Participants are able to be enrolled within ninety days following this
      failure if circumstances preclude approach and consent the morning after titration failure.
      Participants will be asked to wear the Actiwatch for approximately seven days prior to the
      clinical titration polysomnogram (PSG; and again for seven days prior to their final visit .)
      Actiwatch is worn on the participant's wrist to assess sleep continuity. Participants will be
      asked to press the "Marker button" on the Actiwatch when they get in bed each night to have a
      documented time mark when the device is downloaded. Participants will also be asked to fill
      in the sleep diary (provided by sleep clinic) during the seven days (14 days total; 7 at the
      beginning of the study and 7 days prior to the 90 Day visit) they use the Actiwatch.

      Randomization/Therapy Initiated (Visit #1)

      Participants will be randomized and scheduled for a BiPAP® Auto with Bi-Flex® titration or
      CPAP titration night in the lab. General therapy titration guidelines are documented in
      Appendix I & II (see Appendix I & II at end of document). Heart Rate Variability (HRV) will
      be assessed at both the diagnostic portion and titration portion of the research PSG. During
      the diagnostic portion of the research PSG, HRV needs to be assessed for ten minutes while
      the participant is awake. At the end of the titration portion of the research PSG, the HRV
      needs to be assessed for ten consecutive minutes while the participant is awake.

      Enrolled participants will then complete a questionnaire to assess functional outcomes of
      sleep quality (FOSQ), Epworth Sleepiness Scale (ESS), Visual Analog Scale (VAS) for mask
      comfort and satisfaction with therapy, Psychomotor Vigilance Task (PVT), attitudes toward use
      measurement, and Fatigue Severity Scale (FSS; see Appendix III for description of
      measurements).

      Participants will be set up with their respective machines after titration or within ten days
      (10 +/- 2) days of titration and will take these devices home for the next three months.
      Thus, total participation in the trial will be on average 3-4 months. All positive airway
      pressure machines will include a programmed SmartCard to monitor objectively compliance.
      Participants randomized to standard CPAP therapy will receive a SmartCard programmed to
      provide CPAP at their prescribed pressure. Both the participant and the sleep health staff
      administering the questionnaires and psychomotor vigilance task, will be blinded to the
      therapy the SmartCard is programmed to provide. Participants randomized to novel therapy will
      receive a SmartCard programmed to provide BiPAP® Auto with Bi-Flex®. The SmartCard
      programming will be done by an unblinded study staff member. The settings for the novel
      therapy will be:

        -  Min Expiratory Positive Airway Pressure (EPAP) = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O
           (use 6 cmH2O for prescribed CPAP > 10 cmH2O)

        -  Max Inspiratory Positive Airway Pressure (IPAP) = 25 cm H2O

        -  Min Pressure Support (PS) = 2 cm H2O (cannot be adjusted)

        -  MaxPS = 8 cm H2O

        -  Bi-Flex setting of 3

      The SmartCard is inserted into the device to provide the programmed therapy. Both the
      participant and CPAP therapist will be blinded to the therapy the SmartCard is programmed to
      provide. The other supplies necessary to use the therapy at home will also be provided to the
      participant (i.e. mask, tubing, humidifier, etc.).

      The CPAP therapist will also provide the training necessary to use the device at home and
      provide a number to call in case the participant encounters any difficulty using the device
      at home.

      Standardized Counseling to Optimize Adherence to Therapy

      Counseling to optimize adherence to CPAP therapy will consist of:

        1. The clinician will discuss complaints regarding CPAP therapy to identify potential
           contributors to poor adherence to therapy. The standardized counseling to optimize
           adherence includes the following measures to address patient complaints and concerns:

           Interface

             -  Assure current mask is properly applied and headgear is properly adjusted.

             -  Persistent mask leaks or mask discomfort, skin trauma, or skin irritation will be
                addressed first by verifying mask and headgear adjustment and mask sizing. An
                alternate mask can be used if the problems cannot be addressed by fit or adjustment
                interventions.

             -  If mouth leaks are the primary concern and a nasal mask is being used, then a
                nasal/oral mask will be considered or a chin strap will be offered in combination
                with nasal mask use.

           Therapy Side Effects

             -  All patients will have initially been placed on a CPAP device with heated
                humidification. For continued oro-pharyngeal dryness, nasal dryness, nasal
                congestion, or rhinitis, humidification will be increased. Saline nasal sprays,
                steroids, or decongestants can be prescribed, if needed.

             -  Dyspnea on CPAP or claustrophobia will be addressed with counseling as needed.

             -  Note: Reducing the prescribed pressure to improve adherence will not be considered
                at this time.

        2. A standardized description of obstructive sleep apnea (OSA) and its risks will be
           reviewed with the participant, as well as the American Academy of Sleep Medicine Fact
           Sheet Drowsy Driving (see Appendix III).

        3. A standardized description of the evidence regarding the benefits of positive pressure
           therapy to treat OSA will be reviewed with the participant.

      Participants will be instructed to use the device as much as possible while they are sleeping
      and to also make sure they allow an adequate opportunity to sleep each night.
    

Intervention name(s): CPAP; Auto BiLevel
Intervention type(s): Device; Device
Intervention description(s): Continuous positive airway pressure; Auto Bilevel positive airway pressure with Flex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic