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Sponsored by: |
Clayton Sleep Insititute |
Information provided by: | Clayton Sleep Insititute |
ClinicalTrials.gov Identifier: | NCT00635206 |
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:
Condition | Intervention | Phase |
Obstructive Sleep Apnea |
Device: BiPap auto with Fi Flex Device: Standard CPAP |
Phase III |
MedlinePlus related topics: | Sleep Apnea |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter |
Estimated Enrollment: | 40 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Auto M series device set to Bi Flex
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Device: BiPap auto with Fi Flex
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2: Active Comparator
Set to standard CPAP
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Device: Standard CPAP
CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)
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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.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criterion:
Sub-optimal PSG titration: at least one of the following:
Exclusion Criterion:
Contact: Krista Russell, CCRC | 314-645-6605 | russellk@claytonsleep.com |
United States, Missouri | |||||
Clayton Slep Institute | Recruiting | ||||
St. Louis, Missouri, United States, 63143 | |||||
Contact: Krista Russell, CCRC |
Clayton Sleep Insititute |
Responsible Party: | Clayton Sleep Institute ( Eric Powell, PH. D ) |
Study ID Numbers: | BIPAP Rescue, ABF-2007-MCT-03 |
First Received: | March 6, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00635206 |
Health Authority: | United States: Institutional Review Board |
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