Overview
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.
Description
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.
Eligibility
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.