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

Completed · Phase 3

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 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

Key facts

Study ID
NCT00635206
Run by
Clayton Sleep Insititute
People needed
51
Starts
2007-09-01
Expected to finish
2009-05-01
Last updated by the study team
2009-07-14

Who can join

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

Where it is running

Full record on ClinicalTrials.gov

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