eSATIS: Early Sleep Apnea Treatment in Stroke: A Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation
Automatically Closed · 2016 until 2018
Flügel Dominique, Kägi Georg, Müller Anna
The prevalence of Sleep Disordered Breathing (SDB) after acute stroke is high (over 50% of affected patients in more than 20 studies). SDB after stroke has been found to be associated with a faster progression of stroke severity, with higher blood pressure levels and longer hospitalization in the
acute phase1-3. Chronically, stroke patients with SDB exhibit worse func- tional outcome3, 4 and a higher mortality5-7. The mechanisms leading to the
detrimental effects of SDB on stroke outcome are multiple and include changes of cerebral hemodynamics and brain oxygenation8, 9 as well as a number of humoral (endothelial, coagulatory, metabolic and inflammatory)
and systemic changes10, 11.
Due to the high prevalence of SDB following stroke and its detrimental effects on stroke outcome, it is crucial to investigate whether early treat- ment of central, obstructive and mixed forms of SDB with Adaptive Servo- Ventilation (ASV) has a beneficial effect on stroke outcome, measured by MR-imaging of infarct growth from day 1 to 3 months following stroke and by assessments of clinical and cognitive functioning during the acute phase of stroke and after three months. Results regarding the feasibility of ventila-
tion treatment in stroke survivors are encouraging12-15. However, results on treatment efficacy remain controversial16, 17. Importantly, none of the stud- ies assessed the acute neuroradiological evolution of ischemic tissue under
ASV treatment versus no treatment. Therefore more systematic, random-
ized trials are required that assess efficacy of ventilation treatment on both neuroradiological and clinical/cognitive stroke outcome.
Evidence for a beneficial stroke outcome due to treatment with ASV will change daily clinical practice.
The primary objective of the present trial is to assess whether an immedi- ate onset of ASV treatment in stroke patients with significant SDB (sSDB, Apnea-Hypopnea-Index (AHI) ≥ 30/h) has a favorable effect on infarct growth assessed as the difference in lesion volume before and 90 days after treatment start.
The secondary objectives of the trial are to assess whether an immediate onset of ASV treatment in stroke patients with SDB
- improves short and long-term cortical reorganization
- improves clinical and cognitive outcome
- improves physiological parameters such as blood pressure, endo- thelial function/arterial stiffness, and coagulation and inflammation
- is tolerated and associated with good treatment compliance