To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
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
Best medical treatment for stroke, including rehabilitation
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Portugal
RECRUITINGProportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke.
Time frame: 1 month after stroke
Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) at 4 and 6 months after stroke.
Time frame: 4 and 6 months after stroke
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) to measure improvement in neurological parameters at month 1, 4 and 6 after stroke.
Time frame: 1, 4 and 6 months after stroke
Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™
Time frame: Within 7 days after admission
Adherence in the Servoventilation group
% nights of device use; average hours per night of device use
Time frame: After 1, 4 and 6 months
Efficacy in the Servoventilation group
Apnea-Hypopnea Index
Time frame: After 1, 4 and 6 months
Adverse events monitoring
All AEs occurring within the period of observation for the clinical study must be fully evaluated, documented, reported (if applicable) and archived.
Time frame: Through study completion, an average of 2 years
Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients
Time frame: 1, 4 and 6 months after stroke
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cardiovascular events evaluation 12 months after stroke in all participants.
Time frame: 12 months after stroke