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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
Procedure: auto-titrating continuous positive airway pressure
- 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 ]
- 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 ]
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|
|Principal Investigator:||Dawn M Bravata, MD||Yale School of Medicine; VA Connecticut Healthcare System|