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

Phase 3

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: BiPap auto with Fi Flex; Device: Standard CPAP

• Registration Number: NCT00635206
• Lead Sponsor: Clayton Sleep Insititute

Brief 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-13
• Last Update Posted: 2009-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BiPap auto with Fi Flex	Auto M series device set to Bi Flex
2	Standard CPAP	Set to standard CPAP

Primary Outcome Measures

Name	Time	Method
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.	90 days

Secondary Outcome Measures

Name	Time	Method
ASdherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include: compliance, AHI, HRV, FOSQ, Visual Analog Scale for mask comfort & satisfaction, ESS, PVT, Attitudes toward use, Actigraphy & sleep diary, FSS, & DFS	90 days

Trial Locations

Locations (1)

Clayton Slep Institute; 🇺🇸 St. Louis, Missouri, United States