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Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack

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ClinicalTrials.gov Identifier: NCT00251290
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : March 3, 2009
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Study Description
Brief Summary:

Generalist physicians in the outpatient setting care for 80% of the 300,000 patients who have transient ischemic attacks (TIA) annually in the United States. Despite existing secondary prevention therapies, recurrent ischemic events are common following a TIA. Given the risk of poor outcomes and the important role of the generalist, new therapeutic approaches for patients with TIA are needed that can be applied by generalists to outpatients. This research will develop and evaluate a new therapeutic approach that centers on the observations that sleep-disordered breathing is a risk factor for cerebrovascular and cardiovascular disease, is common in patients with cerebrovascular disease, and is associated with poor outcome following a stroke or TIA. We posit that diagnosing and treating sleep-disordered breathing in the home of TIA patients can improve cerebrovascular and cardiovascular outcomes.

The primary aims are to determine in TIA patients: 1) the prevalence of sleep-disordered breathing, 2) the feasibility of diagnosing and treating sleep-disordered breathing using an auto-titrating continuous positive airways pressure (auto-CPAP) machine within 24-hours of TIA symptom onset, 3) adherence to auto-CPAP, and 4) the effect of auto-CPAP on blood pressure.

We will recruit 80 TIA patients to be randomly assigned to either the intervention or the control groups. Each patient in the intervention group will use an auto-CPAP machine for up to 90 days and will then receive an unattended sleep study using a sleep monitor. Each patient in the control group will receive two unattended sleep studies, one upon enrollment and another after 90 days.

Condition or disease Intervention/treatment Phase
Transient Ischemic Attack Sleep Apnea Procedure: auto-titrating continuous positive airway pressure Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack
Study Start Date : November 2004
Primary Completion Date : September 2007
Study Completion Date : September 2007

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U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: auto-titrating continuous positive airway pressure
    Continuous positive Airway pressure (CPAP) use for 90 days post TIA

Outcome Measures

Primary Outcome Measures :
  1. prevalence of sleep-disordered breathing in patients with TIA, proportion of patients who use auto-CPAP >4 hours per night, and change in systolic blood pressure [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Recurrent vascular events (transient ischemic attack, stroke, myocardial infarction, congestive heart failure requiring hospitalization, and death), sleepiness, cognition, depression, functional status, and quality of life. [ Time Frame: 90 days ]

Eligibility Criteria

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: transient ischemic attack - Exclusion Criteria:age <45 years; respiratory distress or known sleep-disordered breathing; chronic obstructive pulmonary disease (COPD) requiring oxygen; pregnancy; time from symptom onset to beginning of study intervention 72 hours; life expectancy <6 months; cognitive impairment (Mini-Mental Status Exam<20); 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251290

United States, Connecticut
Hospital of St. Raphael
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
VA Connecticut Healthcare System, West Haven Campus
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Robert Wood Johnson Foundation
ResMed Foundation
VA Office of Research and Development
Principal Investigator: Dawn M Bravata, MD Yale School of Medicine; VA Connecticut Healthcare System
More Information

Responsible Party: Dawn M. Bravata, M.D., Roudebush VAMC
ClinicalTrials.gov Identifier: NCT00251290     History of Changes
Other Study ID Numbers: RWJ-GPFS-051081
First Posted: November 9, 2005    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: March 2009

Keywords provided by Yale University:
transient ischemic attack
sleep apnea

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Sleep Apnea Syndromes
Respiratory Aspiration
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases