Simone B Duss1,2, Anne-Kathrin Brill2,3, Sébastien Baillieul4,5, Thomas Horvath1, Frédéric Zubler1, Dominique Flügel6, Georg Kägi6, Gabriel Benz7, Corrado Bernasconi1, Sebastian R Ott3, Lyudmila Korostovtseva8, Yurii Sviryaev8, Farid Salih9, Matthias Endres9, Renaud Tamisier4,5, Haralampos Gouveris10, Yaroslav Winter11, Niklaus Denier12, Roland Wiest12, Marcel Arnold1, Markus H Schmidt1,2, Jean-Louis Pépin4,5, Claudio L A Bassetti13,14,15. 1. Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland. 2. Interdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland. 3. Department of Pulmonary Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland. 4. Grenoble Alpes University, HP2 Laboratory, INSERM U1042, Grenoble, France. 5. Pôle Thorax et Vaisseaux, Grenoble Alpes University Hospital, Grenoble, France. 6. Department of Neurology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland. 7. Department of Pneumology, Cantonal Hospital St Gallen, St. Gallen, Switzerland. 8. Hypertension Department, Somnology Group, Almazov National Medical Research Centre, St. Petersburg, Russia. 9. Department of Neurology, Center for Stroke Research Berlin (CSB), Charité - University Medicine Berlin, Berlin, Germany. 10. Department of Otorhinolaryngology, Medical Centre of the Johannes Gutenberg University, Mainz, Germany. 11. Department of Neurology, Medical Centre of the Johannes Gutenberg University, Mainz, Germany. 12. University Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland. 13. Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland. Claudio.Bassetti@insel.ch. 14. Interdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland. Claudio.Bassetti@insel.ch. 15. Department of Neurology, Sechenov University, Moscow, Russia. Claudio.Bassetti@insel.ch.
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 < 5/h). Patients with significant SDB are randomized to treatment (ASV+ group) or no treatment (ASV- group) from the second night after stroke. In all patients, clinical, physiological and magnetic resonance imaging studies are performed between day 1 (visit 1) and days 4-7 (visit 4) and repeated at day 90 ± 7 (visit 6) after stroke. DISCUSSION: The trial will give information on the feasibility and efficacy of ASV treatment in patients with acute stroke and SDB and allows assessing the impact of SDB on stroke outcome. Diagnosing and treating SDB during the acute phase of stroke is not yet current medical practice. Evidence in favour of ASV treatment from a randomized multicentre trial may lead to a change in stroke care and to improved outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02554487 , retrospectively registered on 16 September 2015 (actual study start date, 13 August 2015), and www.kofam.ch (SNCTP000001521).
RCT Entities:
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 strokepatients with SDB. The evidence for a favourable effect of early SDB treatment in acute strokepatients 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 < 5/h). Patients with significant SDB are randomized to treatment (ASV+ group) or no treatment (ASV- group) from the second night after stroke. In all patients, clinical, physiological and magnetic resonance imaging studies are performed between day 1 (visit 1) and days 4-7 (visit 4) and repeated at day 90 ± 7 (visit 6) after stroke. DISCUSSION: The trial will give information on the feasibility and efficacy of ASV treatment in patients with acute stroke and SDB and allows assessing the impact of SDB on stroke outcome. Diagnosing and treating SDB during the acute phase of stroke is not yet current medical practice. Evidence in favour of ASV treatment from a randomized multicentre trial may lead to a change in stroke care and to improved outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02554487 , retrospectively registered on 16 September 2015 (actual study start date, 13 August 2015), and www.kofam.ch (SNCTP000001521).
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