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Early Sleep Apnea Treatment in Stroke: A Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation

English title Early Sleep Apnea Treatment in Stroke: A Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation
Applicant Bassetti Claudio L.
Number 166827
Funding scheme Investigator Initiated Clinical Trials (IICT)
Research institution Universitätsklinik für Neurologie Inselspital Bern
Institution of higher education University of Berne - BE
Main discipline Neurology, Psychiatry
Start/End 01.06.2016 - 31.10.2020
Approved amount 1'143'710.00
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All Disciplines (3)

Discipline
Neurology, Psychiatry
Clinical Cardiovascular Research
Clinical Pathophysiology

Keywords (9)

sleep apnea; cerebrovascular event; clinical outcome; stroke; sleep disorders; adaptive servo-ventilation; non-invasive ventilation; lesion volume; neuroradiological outcome

Lay Summary (German)

Lead
Trotz fortlaufend verbesserter Notfallbehandlung, bleibt der Hirnschlag eine der häufigsten Ursachen für eine Behinderung im Erwachsenenalter. Jede Intervention zur Verbesserung der Erholung nach Hirnschlag ist somit wichtig. Viele Hirnschlagpatienten leiden auch unter Schlafapnoen, d.h. nächtlichen Atemaussetzern, welche die Erholung beeinträchtigen. Eine frühe Behandlung der Schlafapnoen könnte sich positiv auf die Entwicklung der Hirnverletzung und auf die Rehabilitation der Patienten auswirken. Positive Studienresultate würden die klinische Behandlungsroutine dieser Patienten verändern.
Lay summary

Ziele und Inhalte des Forschungsprojekts
Untersucht wird, ob die Ausdehnung der Hirnläsion durch die Behandlung der Schlafapnoen in den ersten drei Monaten nach Hirnschlag verringert werden kann. Um die klinische Relevanz einer potentiell kleineren Ausdehnung der Hirnläsion unter Behandlung der Schlafapnoen zu evaluieren, wird mittels klinischer Skalen die Funktionsfähigkeit der Patienten im Alltag beurteilt. Zu Beginn und Ende der Therapie wird ebenfalls mittels Magnetresonanztomographie die Ruheaktivität des Gehirns erfasst. Auch die Aufmerksamkeits- und Gedächtnisleistung der Patienten, sowie deren Blutdruck- und Blutwerte wird erhoben.
Zur Stabilisierung und Behandlung der nächtlichen Atemaussetzer wird die Adaptive Servo-Ventilationstherapie (ASV) eingesetzt. Dabei handelt es sich um eine in der Schweiz und Europa anerkannte und zertifizierte Therapie nächtlicher Atemstörungen. Therapieadherenz sowie Therapiesicherheit werden ebenfalls evaluiert.
Um die Patientenzahlen und die die Generalisierbarkeit der Resultate zu erhöhen, werden neben dem Universitätsspital Bern auch weitere schweizerische und europäische Zentren an der Datenerhebung beteiligt sein.

Wissenschaftlicher und gesellschaftlicher Kontext des Forschungsprojekts

2 bis 3 pro 1000 Personen erleiden jedes Jahr einen Hirnschlag. Viele sind danach lebenslänglich beeinträchtigt. Jede Massnahme zur Verbesserung der Erholung ist somit bedeutsam.
Schlafapnoen nach Hirnschlag sind häufig und beeinträchtigen die körperliche und geistige Erholung der Betroffenen. Nach heutiger klinischer Routine werden Schlafapnoen noch nicht standardmässig unmittelbar nach Hirnschlag diagnostiziert und behandelt, sondern meist erst einige Wochen bis Monate danach. Wirkt sich die ASV-Therapie positiv auf die Entwicklung der Hirnläsion nach Hirnschlag aus und verbessert den Erholungsprozess der Patienten, so wird dieses Forschungsprojekt die klinische Routine zum Wohl der Hirnschlagpatienten verändern.

Direct link to Lay Summary Last update: 31.05.2017

Responsible applicant and co-applicants

Employees

Project partner

Publications

Publication
Sleep-Wake Disorders in Stroke—Increased Stroke Risk and Deteriorated Recovery? An Evaluation on the Necessity for Prevention and Treatment
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.
The role of sleep in recovery following ischemic stroke: A review of human and animal data
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.

Collaboration

Group / person Country
Types of collaboration
Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Clinic universitaire physiologie, sommeil et exercice, Centre Hospitalier Universitaire de Grenoble France (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Klinik für Neurologie und Pneumologie, Kantonsspital St. Gallen Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Universitätsmedizin der Johannes Gutenberg-Universität, Klinik für Neurologie und HNO-Klinik Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Almazov National Medical Research Centre, Ministry of Health of Russian Federation, St. Petersburg Russia (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
ESRS Conference Basel 2018 Talk given at a conference Sleep and neuroplasticity during stroke recovery 24.09.2018 Basel, Switzerland Bassetti Claudio L.; Ott Sebastian Robert;
SLEEP Annual Meeting Baltimore 2018 Talk given at a conference Sleep disorders as a risk factor of stroke. Sleep disorders in acute stroke. 02.06.2018 Baltimore, Maryland, United States of America Bassetti Claudio L.;
12th annual meeting Clinical Neuroscience Bern (CNB) Talk given at a conference The role of sleep in recovery following ischemic stroke 08.09.2017 Bern, Switzerland Bassetti Claudio L.;


Awards

Title Year
Ernennung zum Privatdozenten, Antrittsvorlesung am 27.03.2017 2017

Associated projects

Number Title Start Funding scheme
125069 Sleep apnea and acute ischemic stroke: clinical and pathophysiological implications 01.09.2009 Project funding (Div. I-III)
149752 Sleep loss and sleep disorders and their impact on the short- and longterm outcome of stroke 01.03.2014 Project funding (Div. I-III)

Abstract

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.
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