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Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure

NCT01446913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2020-11-18

Study results available
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Summary

The goal of this study is to develop a novel study design to safely and ethically conduct a long-term randomized controlled trial among patients at high risk for both sleep apnea and cardiovascular events that will examine whether effective positive airway pressure(PAP) therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular death)in the first year post event, despite current prevent strategies. Therefore, the treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular outcomes in this high risk population.

Conditions

  • Transient Ischemic Attack
  • Stroke

Interventions

DEVICE

Standard CPAP Intervention

BEHAVIORAL

Enhanced CPAP Intervention

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Indiana University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Henry Yaggi, MD,MPH · Yale University

  • Dawn M Bravata, M.D. · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-12-31
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446913 on ClinicalTrials.gov