Complex Sleep Apnea Syndrome (CompSAS) Resolution Study - NCT00915499-60611 (Clinical Trial 296960)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy296960.aspx
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Chicago |
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State:
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IL |
| Zip Code: |
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60611 |
| Conditions: |
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Complex Sleep Apnea Syndrome |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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 |
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| Study is available at: |
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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 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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