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

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.

Detailed 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.

Official Title
-----------------
A Single-center, Randomized, Open Label, Parallel Arm, Prospective Study to Evaluate the Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

Conditions
-----------------
Stroke, Sleep Apnea

Intervention / Treatment
-----------------
* Device: Adaptive Servoventilation (ASV) therapy
* Other: Best medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASV therapy + best medical treatment for stroke, including rehabilitation<br>Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation. | Device: Adaptive Servoventilation (ASV) therapy<br>* 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<br>Other: Best medical treatment<br>* Best medical treatment for stroke, including rehabilitation<br>|
| Active Comparator: Best medical treatment for stroke, including rehabilitation<br>Best medical treatment for stroke, including rehabilitation. | Other: Best medical treatment<br>* Best medical treatment for stroke, including rehabilitation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke. |  | 1 month after stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | 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™ |  | Within 7 days after admission | 
| Adherence in the Servoventilation group | % nights of device use; average hours per night of device use | After 1, 4 and 6 months | 
| Efficacy in the Servoventilation group | Apnea-Hypopnea Index | 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. | Through study completion, an average of 2 years | 
| Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients |  | 1, 4 and 6 months after stroke | 
| Cardiovascular events evaluation 12 months after stroke in all participants. |  | 12 months after stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, early ventilation, sleep apnea