Sleep apnea syndrome (SAS) is highly prevalent in acute stroke and associated with a worst neurological outcome. Hypoxemia, hyperglycemia and higher blood pressure caused by SAS may increase ischemic phenomenon leading to a bigger stroke size and a worst prognosis.
We designed PISTACIO to assess the effect of SAS treatment by auto-adaptative servo-ventilation (ASV) started the first night after stroke on stroke size progression at 7 days.
PISTACIO is a prospective investigator-initiated randomized pilot-study aiming to recruit 60 patients. We randomize patients with an ischemic stroke to receive SAS treatment by ASV in addition to standard medical care vs standard medical care alone during the first week following stroke. Patients have an MRI at admission and at 7 days. Stroke size is measured by an automatic software, Olea, in both MRI and size progression is analyzed. Stroke prognosis is evaluated with the modified Rankin score à 3 months. SAS prevalence, severity and mechanism are assessed by iterative respiratory polygraphy (the first night in control group and at 7 days and 3 months in both groups). SAS treatment observance is calculated by ASV device and considered sufficient if superior to 4 hours per night.
Primary outcome is the impact of ASV on stroke size progression at 7 days. Secondary objectives are to assess AVS effects on neurological outcome at 3 months, to estimate SAS prevalence after stroke and ASV observance.
PISTACIO will determine feasibility, tolerability of ASV during the first week after stroke and its impact on stroke size progression.
PISTACIO trial is registered as NCT04801069.