NCT04801069Unknown不适用
Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
SOS Attaque Cérébrale2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Infarct progression
研究概览
简要总结
Sleep Apnea Syndrome (SAS) is highly prevalent in acute stroke and it is related to worst outcome. We aim to assess if SAS treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke on brain MRI
- •NIHSS 6-22
- •thrombolysis
排除标准
- •Previous SAS
- •Previous stroke
- •Auto-adaptative Servo-Ventilation Contraindication
结局指标
主要结局
Infarct progression
时间窗: 7 days
Ischemic size at 7 days compared to ischemic size at admission on brain MRI
次要结局
- Neurological outcome(3 months)
- Neurological outcome on NIHSS(3 months)
- Duration of Auto-adaptative Servo-Ventilation use(7 days)
- SAS prevalence(3 months)
- SAS severity(3 months)
- Central apnea index(3 months)
- Obstructive apnea index(3 months)
- Quality of life on SF-12 questionnaire(3 months)
- Quality of sleep on Pittsburgh Sleep Quality Index(3 months)
- Daytime Sleepiness(3 months)
研究者
研究点 (2)
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