Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP)

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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

Key facts

Study ID

NCT02522442

Run by

Philips Respironics

People needed

51

Starts

2007-08-01

Expected to finish

2009-01-01

Last updated by the study team

2019-04-26

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mayo Clinics — Rochester, Minnesota, United States
• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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