Continuous Positive Airway Pressure for the Treatment of Stroke
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|ClinicalTrials.gov Identifier: NCT00368628|
Recruitment Status : Completed
First Posted : August 25, 2006
Last Update Posted : March 3, 2009
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke Sleep Apnea||Procedure: continuous positive airway pressure||Phase 2|
BACKGROUND Sleep apnea occurs in 60-96% of stroke survivors and is associated with poor functional recovery and higher post-stroke mortality. Among patients without stroke, continuous positive airway pressure (CPAP) is a safe and effective treatment for sleep apnea. This feasibility pilot study is a step in planning a future efficacy trial of CPAP for patients with acute ischemic stroke.
OBJECTIVES The primary objectives are, among acute ischemic stroke patients, to: (1) determine the feasibility of performing polysomnography; (2) refine the process for providing CPAP within 48-hours of stroke onset; and (3) determine the effect of CPAP on blood pressure.
METHODS This randomized controlled feasibility study will enroll 100 acute ischemic stroke patients. Intervention patients (N=60) receive CPAP within 48 hours of stroke onset and continuing for up to 30 days. At 30 days post-enrollment, the intervention patients undergo unattended polysomnography. Control (N=40) patients receive unattended polysomnography at baseline and after 30 days.
SIGNIFICANCE CPAP represents an important new potential therapy for acute stroke. CPAP may reduce both the neurological symptom severity of the acute stroke and prevent stroke recurrence.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Continuous Positive Airway Pressure for the Treatment of Acute Ischemic Stroke: A Feasibility Pilot Study|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Procedure: continuous positive airway pressure
- proportion using CPAP within 48-hours of stroke onset [ Time Frame: 72 hours ]
- prevalence of sleep apnea [ Time Frame: 30 days post stroke ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368628
|United States, Connecticut|
|Yale-New Haven Hospital|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Dawn M Bravata, MD||Yale School of Medicine|