Continuous Positive Airway Pressure for the Treatment of Stroke - Full Text View

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00368628

Purpose

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.

Condition	Intervention	Phase
Acute Ischemic Stroke Sleep Apnea	Procedure: continuous positive airway pressure	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Continuous Positive Airway Pressure for the Treatment of Acute Ischemic Stroke: A Feasibility Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

proportion using CPAP within 48-hours of stroke onset [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

prevalence of sleep apnea [ Time Frame: 30 days post stroke ] [ Designated as safety issue: No ]

Enrollment:	55
Study Start Date:	November 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368628

Locations

United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Dawn M Bravata, MD

Yale School of Medicine

More Information

No publications provided

Responsible Party:	Roudebush VAMC ( Dawn M. Bravata, M.D. )
Study ID Numbers:	0405026711
Study First Received:	August 24, 2006
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00368628 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

acute ischemic stroke
sleep apnea
continuous positive airway pressure

Study placed in the following topic categories:

Sleep Apnea Syndromes
Cerebral Infarction
Apnea
Stroke
Respiration Disorders
Vascular Diseases
Central Nervous System Diseases
Sleep Disorders
Dyssomnias

Ischemia
Brain Diseases
Cerebrovascular Disorders
Sleep Disorders, Intrinsic
Respiratory Tract Diseases
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Cerebral Infarction
Apnea
Stroke
Respiration Disorders
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Dyssomnias
Sleep Disorders

Ischemia
Brain Diseases
Cerebrovascular Disorders
Sleep Disorders, Intrinsic
Pathologic Processes
Respiratory Tract Diseases
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on August 12, 2009