Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00836758 |
Recruitment Status
:
Completed
First Posted
: February 4, 2009
Last Update Posted
: July 29, 2010
|
Sponsor:
Philips Respironics
Information provided by:
Philips Respironics
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 3, 2009 | |||
First Posted Date ICMJE | February 4, 2009 | |||
Last Update Posted Date | July 29, 2010 | |||
Study Start Date ICMJE | February 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
|
|||
Original Primary Outcome Measures ICMJE |
The CPAP device breathing event output will result in an apnea-hypopnea index (AHI) that is in diagnostic agreement with the AHI obtained from a full clinical PSG. [ Time Frame: one night ] | |||
Change History | Complete list of historical versions of study NCT00836758 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
Methodological comparisons of AHI, apnea index (AI) and hypopnea index (HI) will demonstrate agreement between the values obtained by PSG and the CPAP device. [ Time Frame: one night ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography | |||
Official Title ICMJE | Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
|||
Condition ICMJE | Sleep Apnea | |||
Intervention ICMJE | 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. |
|||
Study Arms | Experimental: CPAP Device
Breathing event detection by the CPAP device will be compared to breathing event detection by a simultaneous PSG.
Intervention: Device: REMstar Auto with A-Flex |
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | August 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 21 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00836758 | |||
Other Study ID Numbers ICMJE | EDILP-2008-SST-01 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Post-Marketing Clinical Research Manager, Philips/Respironics | |||
Study Sponsor ICMJE | Philips Respironics | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Philips Respironics | |||
Verification Date | July 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |