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

This study has been completed.
Sponsor:
Information provided by:
Philips Respironics
ClinicalTrials.gov Identifier:
NCT00836758
First received: February 3, 2009
Last updated: July 28, 2010
Last verified: July 2010
History of Changes

February 3, 2009
July 28, 2010
February 2009
August 2009   (final data collection date for primary outcome measure)
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00836758 on ClinicalTrials.gov Archive Site
Not Provided
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography
Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared 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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Sleep Apnea
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 21-75
  2. Diagnosis of OSAHS with a baseline AHI ≥ 15 events/hr of sleep assessed January 01, 2007 or later
  3. CPAP prescription of 8cm of H20 or higher
  4. Able and willing to provide written informed consent
  5. Native English speaker

Exclusion Criteria:

  1. Participation in another interventional research study within the last 30 days
  2. 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.
  3. 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.
  4. Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
  5. Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)

  6. Presence of untreated or poorly managed,non-OSAHS related sleep disorders:

    1. moderate to severe periodic limb movements(≥ 30/hr with symptoms or arousals)
    2. arousals associated with periodic limb movements > 10 per hour or
    3. anyone experiencing chronic and severe insomnia.
  7. Consumption of ethanol immediately prior to the research PSG
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836758
EDILP-2008-SST-01
No
Post-Marketing Clinical Research Manager, Philips/Respironics
Philips Respironics
Not Provided
Principal Investigator: Richard Berry, MD University of Florida
Philips Respironics
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP