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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke.
研究概览
简要总结
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke.
时间窗: 1 month after stroke
次要结局
- 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)
研究者
Sílvia Correia
Principal Investigator
Philips Portuguesa S.A.