NCT00635206

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Clayton Sleep Insititute · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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 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

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	BiPap auto with Fi Flex	* 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
DEVICE	Standard CPAP	CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP \> 10 cmH2O)

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-03-13
• Last updated: 2009-07-14

Locations

1 site across 1 country: United States