View Clinical Trial (Medical Research Study)
Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography
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Gainesville |
| State: |
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Florida |
| Zip Code: |
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32606 |
| Conditions: |
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Complex Sleep Apnea - Cheyne-Stokes Respiration - Obstructive Sleep Apnea |
| Purpose: |
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The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy
of the CPAP (continuous positive airway pressure) device compared to simultaneous, attended
clinical polysomnography (PSG) in identifying breathing events in participants previously
diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes
respiration (CSR), or obstructive sleep apnea (OSA).
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Males and females, ages 21-80.
- Able and willing to provide written informed consent.
- Diagnosis of CompSAS or OSA within one year of study participation.
- For participants with CompSAS: (a) Diagnostic PSG with an AHI greater than or equal
to 10 events/hour and CAI greater than or equal to 5 events/hour of sleep or (b) PAP
titration with a CAI greater than or equal to 5 events/hour of sleep.
- For participants with OSA, a diagnostic PSG with an AHI greater than or equal to 15
events/hour of sleep.
- Must have had a CPAP titration such that the necessary PAP level to treat the sleep
disordered breathing is known.
- Agreement to undergo a full-night, in-laboratory PSG on CPAP device.
Exclusion Criteria:
- Participation in an interventional research study within 30 days of study
participation.
- Pre-menopausal females known to be pregnant or who are sexually active and not using
a reliable method of birth control.
- Surgery of the upper airway, nose, sinus, or middle ear within the last 90 days.
- Surgery at any time for the treatment of OSA such as uvulopalatopharyngoplasty
(UPPP).
- Major medical or psychiatric condition that would interfere with the demands of the
study, adherence to positive airway pressure, or the ability to complete the study.
- 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.
- Currently prescribed oxygen therapy.
- Ventilatory induced barotrauma within 6 months of study participation.
- Untreated insomnia.
- Other major medical condition that, in the judgment of the investigator, precludes
participation in this study.
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| NCT ID: |
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NCT01175031 |
| Primary Contact: |
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Principal Investigator
Richard Berry, MD
University of Florida
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| Backup Contact: |
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N/A |
| Location Contact: |
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Gainesville, Florida 32606
United States
Susan Purdy
Phone: 352-265-5240
Email: Susan.Purdy@medicine.ufl.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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