sleep apnea; cerebrovascular event; clinical outcome; stroke; sleep disorders; adaptive servo-ventilation; non-invasive ventilation; lesion volume; neuroradiological outcome
Seiler Andrea, Camilo Millene, Korostovtseva Lyudmila, Haynes Alan G., Brill Anne-Kathrin, Horvath Thomas, Egger Matthias, Bassetti Claudio L. (2019), Prevalence of sleep-disordered breathing after stroke and TIAA meta-analysis, in Neurology
, 92(7), e648-e654.
Duss Simone B., Brill Anne-Kathrin, Bargiotas Panagiotis, Facchin Laura, Alexiev Filip, Manconi Mauro, Bassetti Claudio L. (2018), Sleep-Wake Disorders in Stroke—Increased Stroke Risk and Deteriorated Recovery? An Evaluation on the Necessity for Prevention and Treatment, in Current Neurology and Neuroscience Reports
, 18(10), 72-72.
Manconi Mauro, Fanfulla Francesco, Ferri Raffaele, Miano Silvia, Haba-Rubio Josè, Heinzer Raphael, Horvath Thomas, Proserpio Paola, Young Peter, Moschovitis Giorgio, Seiler Andrea, Cereda Carlo, Nobili Lino, Wiest Roland, Ott Sebastian R., Bassetti Claudio L. (2018), Periodic limb movements during sleep in stroke/TIAPrevalence, course, and cardiovascular burden, in Neurology
, 90(19), e1663-e1672.
Brill Anne-Kathrin, Horvath Thomas, Seiler Andrea, Camilo Millene, Haynes Alan G., Ott Sebastian R., Egger Matthias, Bassetti Claudio L. (2018), CPAP as treatment of sleep apnea after strokeA meta-analysis of randomized trials, in Neurology
, 90(14), e1222-e1230.
Duss Simone B., Seiler Andrea, Schmidt Markus H., Pace Marta, Adamantidis Antoine, Müri René M., Bassetti Claudio L. (2016), The role of sleep in recovery following ischemic stroke: A review of human and animal data, in Neurobiology of Sleep and Circadian Rhythms
, 2, 94-105.
Background and objectives:Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major importance. First, because of the high prevalence of stroke and the fact that it is one of the most frequent causes of long-term disability in adulthood. Second, because SDB affects more than 50% of stroke survivors and has a detrimental effect on clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation. Therefore, it is crucial to investigate whether treatment of SDB has a beneficial effect on the evolution of the lesion volume and on clinical stroke outcome. The present study is the first project worldwide that aims to investigate the impact of immediate treatment of SDB with non-invasive adaptive servo-ventilation (ASV) in acute stroke patients. The primary objective is to test the effect of ASV treatment on the evolution of the lesion volume in ischemic stroke patients with significant SDB, defined as an Apnea-Hypopnea-Index (AHI) > 20/h. Evolution of lesion volume will be assessed as the difference in lesion volume before and 90 days after treatment start. The secondary objectives include assessment of the effects of ASV treatment on clinical and cognitive outcome and on physiological parameters discussed as important risk factors for stroke (blood pressure, endothelial function/arterial stiffness). Also of major importance is to investigate how tolerance of ASV and treatment compliance are associated with clinical outcome. Moreover, we investigate whether ASV improves short- and long-term cortical network reorganization assessed by functional resting state imaging.Design and methods:In a multicenter open-label randomized trial three groups of patients will be prospectively followed over 1 year. Group assignment is scheduled the day following stroke after the assessment of SDB by nocturnal respiratory polygraphy. Patients with an AHI > 20/h are randomized to ASV treatment or no treatment (SDB ASV+ or SDB ASV-). Stroke patients without SDB (AHI < 5/h) form a control group (no SDB) to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB. ASV treatment is started at the second night following ischemic stroke and ends 90 days later. The multicentric design involving four highly expertized clinics in stroke, sleep and pulmonary medicine would allow us to include a higher number of patients than currently possible in the single center study and to perform also additional analyses with different patients’ subgroups (e.g., according to severity of SDB and stroke). A multicenter trial will also increase generalizability of results and therefore meets the highest standards of research. The recruitment process could be accelerated and potential positive results could be sooner made available to patients. The planned trial would be conducted with the Clinical Trial Unit Bern with the involvement of local CTUs. Bern University Hospital is the driving force of the current project and will take over coordination duties.Implication:Positive evidence for a reduction of lesion volume and improvement of stroke outcome due to ASV treatment based on the randomized, multicentre research project, would set new standards in stroke patients’ care and improve patients’ wellbeing.