Sleep-disordered breathing in acute ischemic stroke and transient ischemic attack: effects on short- and long-term outcome and efficacy of treatment with continuous positive airways pressure--rationale and design of the SAS CARE study.

OBJECTIVES: Sleep-disordered breathing represents a risk factor for cardiovascular morbidity and mortality and negatively affects short-term and long-term outcome after an ischemic stroke or transient ischemic attack. The effect of continuous positive airways pressure in patients with sleep-disordered breathing and acute cerebrovascular event is poorly known. The SAS CARE 1 study assesses the effects of sleep-disordered breathing on clinical evolution, vascular functions, and markers within the first three-months after an acute cerebrovascular event. The SAS CARE 2 assesses the effect of continuous positive airways pressure on clinical evolution, cardiovascular events, and mortality as well as vascular functions and markers at 12 and 24 months after acute cerebrovascular event.
METHODS: SAS CARE 1 is an open, observational multicenter study in patients with acute cerebrovascular event acutely admitted in a stroke unit: a sample of 200 acute cerebrovascular event patients will be included. Vascular functions and markers (blood pressure, heart rate variability, endothelial function by peripheral arterial tonometry and specific humoral factors) will be assessed in the acute phase and at three-months follow-up. SAS CARE 2 will include a sample of patients with acute cerebrovascular event in the previous 60-90 days. After baseline assessments, the patients will be classified according to their apnea hypopnea index in four arms: non-sleep-disordered breathing patients (apnea hypopnea index <10), patients with central sleep-disordered breathing, sleepy patients with obstructive apnea hypopnea index ≥20, which will receive continuous positive airways pressure treatment, nonsleepy patients with obstructive sleep-disordered breathing (apnea hypopnea index ≥20), which will be randomized to receive continuous positive airways pressure treatment or not.
CONCLUSIONS: The SAS CARE study will improve our understanding of the clinical sleep-disordered breathing in patients with acute cerebrovascular event and the feasibility/efficacy of continuous positive airways pressure treatment in selected patients with acute cerebrovascular event and sleep-disordered breathing.

RCT Entities:   Population Interventions Outcomes