Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography
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|ClinicalTrials.gov Identifier: NCT00836758|
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : July 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Device: REMstar Auto with A-Flex||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836758
|United States, Florida|
|Shands and UF Sleep Disorder Center|
|Gainesville, Florida, United States, 32606|
|Principal Investigator:||Richard Berry, MD||University of Florida|