Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack
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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 |
- 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 ]
- 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) |
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Procedure: auto-titrating continuous positive airway pressure
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| 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.
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Contacts and 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 | |
| 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:
|
Apnea Respiratory Aspiration Ischemic Attack, Transient Ischemia Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Brain Ischemia |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders |
ClinicalTrials.gov processed this record on May 19, 2013