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

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
ResMed Foundation
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00251290
First received: November 7, 2005
Last updated: March 2, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Transient Ischemic Attack
Sleep Apnea
Procedure: auto-titrating continuous positive airway pressure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: November 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: auto-titrating continuous positive airway pressure
    Continuous positive Airway pressure (CPAP) use for 90 days post TIA
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00251290

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

No publications provided

Responsible Party: Dawn M. Bravata, M.D., Roudebush VAMC
ClinicalTrials.gov Identifier: NCT00251290     History of Changes
Other Study ID Numbers: RWJ-GPFS-051081
Study First Received: November 7, 2005
Last Updated: March 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
transient ischemic attack
sleep apnea

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

ClinicalTrials.gov processed this record on October 19, 2014