N/A
N=48
Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP)
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02522442 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Group Compliance of the Auto Bilevel Group Compared to the CPAP Group Measured by Average Nightly Use. — 284.7; 255.1 minutes/night — p=0.377
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP (Device); Auto BiLevel (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Group Compliance of the Auto Bilevel Group Compared to the CPAP Group Measured by Average Nightly Use. |
284.7; 255.1 | 0.377 |
| PRIMARY Percentage of Group Compliance of the Auto Bilevel Group Compared to the CPAP Group |
62; 55 | .624 |
| SECONDARY Epworth Sleepiness Scale |
9.7; 8.2; 8.2; 6.6; 8.1; 6.9 | — |
| SECONDARY Fatigue Severity Scale |
4.6; 3.9; 4.0; 3.7; 3.9; 3.4 | — |
| SECONDARY Functional Outcomes of Sleep Quality |
84.0; 91.4; 97.5; 96.6; 100.0; 100.1 | — |
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
Eligibility Criteria
Participants who meet the inclusion/exclusion criterion below and are willing to participate in the protocol when contacted will be enrolled into the study. Participants need to meet all of the following inclusion criterion below:
Inclusion Criterion:
- Age 21-75
- New Diagnosis of OSA with a baseline respiratory disturbance index (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 periodic limb movement (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 Criteria
- 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 Chronic Obstructive Pulmonary Disease (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)
Data sourced from ClinicalTrials.gov (NCT02522442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.