Simone B. Duss, Anne-Kathrin Brill, Sébastien Baillieul, Thomas Horvath, Frédéric Zubler, Dominique Flügel, Georg Kägi, Gabriel Benz, Corrado Bernasconi, Sebastian R. Ott, Lyudmila Korostovtseva, Yurii Sviryaev, Farid Salih, Matthias Endres, Renaud Tamisier, Haralampos Gouveris, Yaroslav Winter, Niklaus Denier, Roland Wiest, Marcel Arnold, Markus H. Schmidt, Jean-Louis Pépin, and Claudio L. A. Bassetti
Abstract Background Sleep-disordered breathing (SDB) is highly prevalent in acute ischaemic stroke and is associated with worse functional outcome and increased risk of recurrence. Recent meta-analyses suggest the possibility of beneficial effects of nocturnal ventilatory treatments (continuous positive airway pressure (CPAP) or adaptive servo-ventilation (ASV)) in stroke patients with SDB. The evidence for a favourable effect of early SDB treatment in acute stroke patients remains, however, uncertain. Methods eSATIS is an open-label, multicentre (6 centres in 4 countries), interventional, randomized controlled trial in patients with acute ischaemic stroke and significant SDB. Primary outcome of the study is the impact of immediate SDB treatment with non-invasive ASV on infarct progression measured with magnetic resonance imaging in the first 3 months after stroke. Secondary outcomes are the effects of immediate SDB treatment vs non-treatment on clinical outcome (independence in daily functioning, new cardio-/cerebrovascular events including death, cognition) and physiological parameters (blood pressure, endothelial functioning/arterial stiffness). After respiratory polygraphy in the first night after stroke, patients are classified as having significant SDB (apnoea-hypopnoea index (AHI) > 20/h) or no SDB (AHI