Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke.

The study will consist of screening, baseline assessment, interventional period (consisting of a treatment period and follow-up visits), and a follow-up phone call.

Patients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.

Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.

Inclusion criteria

• Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
• Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
• Admission to the hospital within 48 h of stroke symptoms onset.
• Ischemic first stroke diagnosis.
• NIHSS ≥2 at screening.
• Sleep apnea with AHI ≥15.

Exclusion criteria

• CSA with Left Ventricular Ejection Fraction ⩽45%.
• Ventilation treatment for sleep apnea diagnosis, prior to stroke.
• Risk of aspiration.
• Nasogastric feeding tube.
• Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
• Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
• Cardiorespiratory distress.
• Advanced chronic lung disease requiring supplemental oxygen.
• Concomitant central nervous system diseases such as dementia or multiple sclerosis.
• Uncontrolled psychosis or agitation.
• Glasgow Coma Scale (GCS) score <10 at screening.
• Anosognosia, global or Wernicke aphasia.
• Insufficient upper limbs function to use a mask and no overnight caregiver to help.
• Inability to attend to the rehabilitation program of the hospital.
• Pregnant and breast-feeding women.
• Participation in another clinical study (except a standard-of-care registry).
• Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.