Evidence map›Paper›PMID 33482893›Full record

ArticleTrials2021

Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke).

Simone B Duss, Anne-Kathrin Brill, Sébastien Baillieul, Thomas Horvath, Frédéric Zubler, Dominique Flügel, Georg Kägi, Gabriel Benz, Corrado Bernasconi, Sebastian R Ott and 13 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02554487 (Early Sleep Apnea Treatment in Stroke), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02554487 naunknown statusnot on this map

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

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2015 to 2022Enrolled201ConditionsSleep Apnea, Obstructive, Sleep Apnea, Central, StrokeArmsAirCurveTM10 CS PACEWAVE Adaptive-Servo-Ventilator (ResMed Ldt., Australia)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 7 institutions in 4 countries.

Simone B DussDepartment of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Anne-Kathrin BrillInterdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Sébastien BaillieulGrenoble Alpes University, HP2 Laboratory, INSERM U1042, Grenoble, France.
Thomas HorvathDepartment of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Frédéric ZublerDepartment of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Dominique FlügelDepartment of Neurology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Georg KägiDepartment of Neurology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Gabriel BenzDepartment of Pneumology, Cantonal Hospital St Gallen, St. Gallen, Switzerland.
Corrado BernasconiDepartment of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Sebastian R OttDepartment of Pulmonary Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Lyudmila KorostovtsevaHypertension Department, Somnology Group, Almazov National Medical Research Centre, St. Petersburg, Russia.
Yurii SviryaevHypertension Department, Somnology Group, Almazov National Medical Research Centre, St. Petersburg, Russia.
Farid SalihDepartment of Neurology, Center for Stroke Research Berlin (CSB), Charité - University Medicine Berlin, Berlin, Germany.
Matthias EndresDepartment of Neurology, Center for Stroke Research Berlin (CSB), Charité - University Medicine Berlin, Berlin, Germany.
Renaud TamisierGrenoble Alpes University, HP2 Laboratory, INSERM U1042, Grenoble, France.
Haralampos GouverisDepartment of Otorhinolaryngology, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.
Yaroslav WinterDepartment of Neurology, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.
Niklaus DenierUniversity Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Roland WiestUniversity Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Marcel ArnoldDepartment of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Markus H SchmidtDepartment of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Jean-Louis PépinGrenoble Alpes University, HP2 Laboratory, INSERM U1042, Grenoble, France.
Claudio L A BassettiDepartment of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland. Claudio.Bassetti@insel.ch.ORCID http://orcid.org/0000-0002-4535-0245
University of Bern · CHInserm · FRCharité - Universitätsmedizin Berlin · DEFederal Almazov North-West Medical Research Centre · RUJohannes Gutenberg University Mainz · DEKantonsspital St. Gallen · CHUniversity of St.Gallen · CH

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 320030_149752Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 33IC30_166827
6 · The paper itself

Abstract

backgroundSleep-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.

methodseSATIS 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 registrationClinicalTrials.gov NCT02554487 , retrospectively registered on 16 September 2015 (actual study start date, 13 August 2015), and www.kofam.ch (SNCTP000001521).

Indexed as

Brain IschemiaHeart FailureSleep Apnea SyndromesStrokeHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicStroke VolumeTreatment OutcomeAdaptive servo-ventilationMRI evolutionOutcomeRandomized controlled trialSleep-disordered breathingStrokeTreatment

Identifiers

PMID33482893
PMCPMC7820538
OpenAlexW3123239742

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.