Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography

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; (submitted: July 28, 2010)	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; (submitted: February 3, 2009)	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; (submitted: February 3, 2009)	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; (submitted: February 3, 2009)	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: Age 21-75; Diagnosis of OSAHS with a baseline AHI ≥ 15 events/hr of sleep assessed January 01, 2007 or later; CPAP prescription of 8cm of H20 or higher; Able and willing to provide written informed consent; Native English speaker Exclusion Criteria: Participation in another interventional research study within the last 30 days; Major medical or psychiatric condition that would interfere with the demands of the study and adherence to PAP. Examples include unstable cardiovascular disease (Class III / IV CHF), neuromuscular disease, cancer, and renal failure.; Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake, or subjects requiring continuous oxygen therapy.; Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days; Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP); Presence of untreated or poorly managed,non-OSAHS related sleep disorders: moderate to severe periodic limb movements(≥ 30/hr with symptoms or arousals) arousals associated with periodic limb movements > 10 per hour or anyone experiencing chronic and severe insomnia.; Consumption of ethanol immediately prior to the research PSG
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Richard Berry, MD University of Florida
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