Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00635206
Status:
COMPLETED
Last Update Posted:
2009-07-14
First Post:
2008-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
Sponsor:
Clayton Sleep Insititute
Organization:
Study Overview
Official Title:
Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIPAP
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
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ABF-2007-MCT-03 | None | None | View |