Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy|
- Hours Used [ Time Frame: 30 days ] [ Designated as safety issue: No ]The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.
|Study Start Date:||September 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Fixed Mode + Acclimate
S9 Elite flow generator with Acclimate feature activated.
Device: S9 Elite with Acclimate
S9 Elite Flow Generator with Acclimate feature activated
Active Comparator: Fixed Mode only
S9 Elite Flow Generator with Fixed Mode only
Device: S9 Elite
S9 Elite Flow Generator
Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421654
|United States, New York|
|Rochester, New York, United States, 14625|
|Principal Investigator:||Ken Plotkin, MD||Sleep Insights|