Continuous Positive Airway Pressure for the Treatment of Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368628
• Other study ID #: 0405026711
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2006
• Last updated: March 2, 2009
• Start date: November 2004
• Est. completion date: March 2008

Study information

• Verified date: March 2009
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Sleep Apnea
• Stroke

Intervention

Procedure:
• continuous positive airway pressure
Continuous Positive Airway Pressure initiated within 48 hours of stroke onset and continued for 90 days.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion using CPAP within 48-hours of stroke onset		72 hours	No
Secondary	prevalence of sleep apnea		30 days post stroke	No