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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Philips Portuguesa S.A.
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Proportion 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
Secondary Outcomes
- Efficacy in the Servoventilation group(After 1, 4 and 6 months)
- Cardiovascular events evaluation 12 months after stroke in all participants.(12 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(After 1, 4 and 6 months)
- 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)
- Adverse events monitoring(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)
Investigators
Sílvia Correia
Principal Investigator
Philips Portuguesa S.A.