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

Primary Purpose

Transient Ischemic Attack, Sleep Apnea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
auto-titrating continuous positive airway pressure
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Ischemic Attack focused on measuring transient ischemic attack, sleep apnea

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Hospital of St. Raphael
  • Yale-New Haven Hospital
  • VA Connecticut Healthcare System, West Haven Campus

Outcomes

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

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.

Full Information

First Posted
November 7, 2005
Last Updated
March 2, 2009
Sponsor
Yale University
Collaborators
Robert Wood Johnson Foundation, ResMed Foundation, US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00251290
Brief Title
Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack
Official Title
Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
Robert Wood Johnson Foundation, ResMed Foundation, US Department of Veterans Affairs

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Sleep Apnea
Keywords
transient ischemic attack, sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
auto-titrating continuous positive airway pressure
Intervention Description
Continuous positive Airway pressure (CPAP) use for 90 days post TIA
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M Bravata, MD
Organizational Affiliation
Yale School of Medicine; VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of St. Raphael
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
VA Connecticut Healthcare System, West Haven Campus
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

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

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