View Clinical Trial (Medical Research Study)
Treatment of Obstructive Sleep Apnea After Stroke
| City: |
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Ann Arbor |
| State: |
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Michigan |
| Zip Code: |
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48109 |
| Conditions: |
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Obstructive Sleep Apnea - Stroke |
| Purpose: |
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The purpose of this study is to determine if treating stroke patients who have obstructive
sleep apnea with continuous positive airway pressure will improve symptoms caused by the
stroke.
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| Study Summary: |
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Stroke is the leading cause of adult disability in the United States, yet there are very few
treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper
airway blockage that occurs during sleep--is common after stroke, affecting more than half
of stroke patients. The most common treatment for obstructive sleep apnea in the general
population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask
during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open
during sleep.
The objective of this single-center, prospective, randomized study is to evaluate CPAP
treatment in post-stroke patients. Participants will go through a medical interview, a
brief neurological examination, and a sleep study to screen them for OSA. Those with OSA
will be eligible for the second phase of the study during which participants will be
randomly selected to receive either treatment with CPAP or with sham CPAP (placebo).
This project promises to establish feasibility, develop design and identify suitable outcome
measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue,
and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with
OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all
stroke patients will become available.
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| Criteria: |
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Inclusion Criteria:
- Ischemic stroke within 7 days of planned polysomnography/sleep screening study
- Modified Rankin Scale score >1
- If of child-bearing potential, has a negative urine or serum pregnancy test
Exclusion Criteria:
- Decompensated heart failure
- Cardiac or respiratory arrest within the past 3 months
- Myocardial infarction within the past 3 months
- Severe pneumonia
- Hypertension refractory to treatment
- Any other unstable medical condition which is thought to interfere with participation
- Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP
- Previous pneumothorax
- Bullous emphysema
- COPD, obesity-hypoventilation, or another condition warranting the use of nasal
bilevel positive airway pressure instead of CPAP
- Acute sinus or ear infection
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| NCT ID: |
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NCT00282815 |
| Primary Contact: |
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Principal Investigator
Devin Brown, MD, MS
Associate Professor, Stroke Program, University of Michigan
Devin Brown, MD, MS
Phone: (734) 936-9075
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| Backup Contact: |
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N/A |
| Location Contact: |
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Ann Arbor, Michigan 48109
United States
Devin Brown, MD, MS
Phone: 734-936-9075
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
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