Continuous Positive Airway Pressure for the Treatment of Stroke

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00368628
First received: August 24, 2006
Last updated: March 2, 2009
Last verified: March 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure for the Treatment of Acute Ischemic Stroke: A Feasibility Pilot Study

Resource links provided by NLM:


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:
    Procedure: continuous positive airway pressure
    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
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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 by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dawn M. Bravata, M.D., Roudebush VAMC
ClinicalTrials.gov Identifier: NCT00368628     History of Changes
Other Study ID Numbers: 0405026711
Study First Received: August 24, 2006
Last Updated: March 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
acute ischemic stroke
sleep apnea
continuous positive airway pressure

Additional relevant MeSH terms:
Apnea
Ischemia
Sleep Apnea Syndromes
Stroke
Cerebral Infarction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014