Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography
The purpose of this study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography|
- Evidence of diagnostic agreement between breathing events identified by the CPAP device compared to a simultaneous PSG confirmed by using accepted sleep disordered breathing severity groupings (AHI >5, AHI >15 and AHI >30). [AHI is apnea-hypopnea index] [ Time Frame: one night ] [ Designated as safety issue: No ]Participants will undergo an attended PSG using the CPAP device at a sub-therapeutic pressure in order to induce breathing events. The breathing event outputs for both the PSG and CPAP device will be compared to determine if the apnea-hypopnea indices are in diagnostic agreement.
|Study Start Date:||February 2009|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: CPAP Device
Breathing event detection by the CPAP device will be compared to breathing event detection by a simultaneous PSG.
Device: REMstar Auto with A-Flex
The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836758
|United States, Florida|
|Shands and UF Sleep Disorder Center|
|Gainesville, Florida, United States, 32606|
|Principal Investigator:||Richard Berry, MD||University of Florida|