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Completed

NCT Number: NCT00368628

Continuous Positive Airway Pressure for the Treatment of Stroke

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Continuous Positive Airway Pressure

Procedure

Continuous Positive Airway Pressure initiated within 48 hours of stroke onset and continued for 90 days.

Primary outcomes

  1. proportion using CPAP within 48-hours of stroke onset

    Time frame: 72 hours

Secondary outcomes

  1. prevalence of sleep apnea

    Time frame: 30 days post stroke

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 25, 2006
Registry last updated
Mar 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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