Status:
TERMINATED
Sleep Apnea Treatment After Stroke (SATS)
Lead Sponsor:
University of Michigan
Conditions:
Obstructive Sleep Apnea
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP
- Acute sinus or ear infection
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00282815
Start Date
September 1 2004
End Date
May 1 2010
Last Update
March 11 2013
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109