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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
  Purpose

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 Intervention
Sleep Apnea
 Device: REMstar Auto with A-Flex

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Post-Marketing Clinical Research Manager, Philips/Respironics
ClinicalTrials.gov Identifier: NCT00836758     History of Changes
Other Study ID Numbers: EDILP-2008-SST-01
Study First Received: February 3, 2009
Last Updated: July 28, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013