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Complex Sleep Apnea Syndrome (CompSAS) Resolution Study - NCT00915499-60611(Clinical Trial 296960)



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City:  Chicago
State:  
IL
Zip Code: 60611
Conditions: Complex Sleep Apnea Syndrome
Purpose: The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.
Study summary: Between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (OSA) develop a high-frequency of central apneas and/or disruptive Cheyne-Stokes respiratory syndrome after application of continuous positive airway pressure (CPAP), a pattern called the complex sleep apnea syndrome (CompSAS). The trial seeks to determine the efficacy of the ASV vs. CPAP modes for the treatment of CompSAS over time. Baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. Overall study participation is approximately 3 months.
Criteria: Inclusion Criteria: - Diagnosis of complex sleep apnea syndrome (CompSAS) - Naive to PAP therapy - Requires CPAP ≤15 cm H2O Exclusion Criteria: - Requires supplemental oxygen or with a baseline SaO2 <90% - Requires CPAP > 15 cm H2O - Primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure - Any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status
Study is available at: Northwestern University
Chicago, IL 60611
United States

Primary Contact:
Helen K Donnelly, RN, BSN, CCRC
Email: h-donnelly@northwestern.edu

Secondary Contact:
June Mendoza
Email: june.mendoza@resmed.com
Phone: 800-424-0737
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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