Stroke Clinical Trial
Official title:
Treatment of Obstructive Sleep Apnea After Stroke
Verified date | December 2012 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 32 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. | 3 months | No | |
Primary | Number of Subjects Who Withdraw From Study. | Prespecified outcome. | 3 months | No |
Secondary | Barthel Index | Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent). | 3 months | No |
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