Sleep Apnea Clinical Trial
Official title:
Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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