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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
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 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), ESS, Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy, Psychomotor Vigilance Task, attitudes toward use measurement, and Fatigue Severity Scale (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 PAP 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:
- 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
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:
- 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 OSA and its risks will be reviewed with the participant, as well as the AASM 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Obstructive Sleep Apnea
CPAP, Auto BiLevel
Brigham and Women's Hospital
Published on BioPortfolio: 2015-08-14T19:23:23-0400
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