Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter

Study Overview
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Brief Summary
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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: 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
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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.

Official Title
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Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: BiPap auto with Fi Flex
* Device: Standard CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criterion: Age 21-75 New Diagnosis of OSA with a baseline RDI ≥ 15 events/hr of sleep determined by either full night or split night PSG Able and willing to provide written informed consent Able to follow study procedures Sub-optimal PSG titration with at least 3 hours of attempted PAP titration (defined below): and deemed by their physician as a titration failure Sub-optimal PSG titration: at least one of the following: Poor sleep efficiency during titration period (sleep efficiency ≤ 70%) (participants may be on sleep medications as per standard lab CPAP protocol ) or; Frequent arousals based on three seconds of alpha frequency on EEG (non PLM-related) of 20 or greater per hour during the titration portion of the study or; CPAP titration aborted due to participant's request (due to intolerance), or Persistent sleep disruption despite therapeutic CPAP therapy and in the judgment of the reviewing physician, suggesting a low probability to CPAP adherence Exclusion Criterion: Participation in another interventional research study within the last 30 days Major uncontrolled medical or psychiatric condition such as congestive heart failure, neuromuscular disease, renal failure etc. Prior CPAP or Bi-Level PAP use (within last 2 years) Chronic respiratory failure or insufficiency, moderate COPD (FEV1 < 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days Presence of an untreated, diagnosable, non-OSA related sleep disorder (e.g. restless legs syndrome, insomnia, etc.) Periodic Limb movement arousal index of 10 or greater. Refusal to consider further interventions to standard CPAP to optimize positive pressure therapy (e.g. different mask than what was used in lab) PAP therapy otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks Shift workers or people experiencing jet lag Known history of alcohol and or drug abuse Diagnosis of Complex Sleep Apnea, (appears to be classic obstructive or mixed sleep apnea, but exhibits disruptive central apneas and periodic breathing on CPAP) 11, 12 or persistent central apnea during diagnostic PSG. Diagnosis of Attention Deficit Hyperactivity Disorder Chronic Hypnotic use (nightly use for three months or less)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Auto M series device set to Bi Flex | Device: BiPap auto with Fi Flex<br>* 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<br>|
| Active Comparator: 2<br>Set to standard CPAP | Device: Standard CPAP<br>* CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA