Continuous Positive Airway Pressure for the Treatment of Stroke

Condition(s) targeted: Acute Ischemic Stroke; Sleep Apnea

Intervention: continuous positive airway pressure (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Dawn M Bravata, MD, Principal Investigator, Affiliation: Yale School of Medicine

Overall contact:
Dawn M Bravata, MD, Phone: 203-932-5711, Ext: 4240, Email: dawn.bravata@yale.edu

New stroke therapies are needed. This study seeks to provide the preliminary data needed to plan a future study that will evaluate the efficacy of using continuous positive airway pressure (CPAP) to treat stroke patients who have sleep apnea. Our goal is to use this therapy to reduce stroke symptom severity.

Official title: Continuous Positive Airway Pressure for the Treatment of Acute Ischemic Stroke: A Feasibility Pilot Study

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome:

proportion with complete polysomnography data

proportion using CPAP within 48-hours of stroke onset

number of hours of CPAP use per night

proportion of possible nights CPAP used

change in systolic blood pressure

Secondary outcome:

prevalence of sleep apnea

severity of sleep apnea

Detailed description: 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.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: acute ischemic stroke with NIH Stroke Scale >=2 -

Exclusion Criteria: respiratory distress; COPD requiring oxygen; primary intracranial hemorrhage on admission brain imaging; time from symptom onset to sleep study or CPAP treatment >72 hours or time from hospital admission to sleep study or CPAP treatment >48 hours; life expectancy less than 6 months; inability to provide informed consent; inability to communicate in English; residence outside the greater New Haven area; or any condition where the monitoring required by the study would constitute a risk to the patient or impair his or her care.

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Dawn M Bravata, MD, Phone: 203-932-5711, Ext: 4240, Email: dawn.bravata@yale.edu

Yale-New Haven Hospital, New Haven, Connecticut 06520, United States; Recruiting
Frederick Struve, PhD, Phone: 203-932-5711, Ext: 4240, Email: frederick.struve@yale.edu

Starting date: November 2004
Ending date: January 2008
Last updated: August 24, 2006