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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
Sponsor:
Information provided by:
Philips Respironics

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.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Florida
Shands and UF Sleep Disorder Center
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Richard Berry, MD University of Florida

Responsible Party: Post-Marketing Clinical Research Manager, Philips/Respironics
ClinicalTrials.gov Identifier: NCT00836758     History of Changes
Other Study ID Numbers: EDILP-2008-SST-01
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: July 2010