Study of Sleep Apnea and Heart or Brain Event Risks After a First Stroke or TIA

What this Trial Is About

Researchers are studying the occurrence of major heart and brain-related events in patients after their first stroke, first transient ischemic attack TIA, or recurrent TIA. This research compares patients with sleep-disordered breathing SDB to those without SDB one year after diagnosing SDB three months post-stroke. The primary focus is on a combined measure of serious cardiac or brain events including death, non-fatal stroke, and acute coronary disease. The study includes 1620 patients aged 18 to 85 who are in the acute phase of a stroke or TIA and have low disability before the event. Patients will be grouped based on polysomnography results performed three months after their stroke or TIA to diagnose SDB, defined by an apnea-hypopnea index higher than 15 events per hour. Those with SDB will receive treatment according to standard care, such as Continuous Positive Airway Pressure CPAP, mandibular advancement devices, positional therapy, adaptive servo-ventilation, or non-invasive ventilation. The study follows patients over five years, with assessments at enrollment, three months, and annually after SDB diagnosis. Participants undergo detailed clinical, imaging, cognitive, sensorimotor, and biological evaluations at various points, including stroke imaging, blood sampling, and questionnaires on quality of life, depression, and sleep. Regular follow-up assesses new cardiac or cerebrovascular events, stroke-related outcomes, treatment adherence, and cognitive and functional abilities. An ancillary study focuses on patients eligible for carotid surgery, evaluating plaque changes and molecular markers. The primary outcome measure is collected one year after SDB diagnosis, with long-term monitoring continuing up to five years.

Apnea, Stroke and Incident Cardiovascular Events