Feasibility Evaluation of Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- CPAP feasibility
研究概览
简要总结
This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is associated with worse functional outcomes and higher mortality in the post-stroke period. Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary treatment for obstructive sleep apnea.
Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one randomised trial has provided the means to document neurological improvement at mid term (1 month) in a targeted population.
Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •- Clinical presentation of ischemic stroke confirmed by imaging (CT or MRI brain scan)
- •less than 24 hours from onset of symptoms
- •admitted to the Neurovascular unit of the Emergency Hospitalisation Department of 'Hôpital Nord' of the university hospital of Saint-Étienne
- •presenting obstructive sleep apnea syndrome (defined as an apnea-hypopnea index (AHI) of ≥ 10 and > 50% of obstructive events)
- •written consent of patient
排除标准
- •Concussion (Coma Glasgow Score <12)
- •Comprehension aphasia
- •Uncontrollable confusion and agitation
- •History of dementia
- •History of ischemic stroke with neurological damage
- •History of hemorrhagic stroke
- •History of epilepsy
- •Cerebrospinal fluid leak, recent cranial surgery or head injury
- •Serious bullous lung disease
- •Hypoxic pulmonary disease
- •Pleurisy or pneumothorax requiring draining
- •Respiratory distress requiring mechanical ventilation
- •Oxygen therapy prior to stroke
- •Non-invasive ventilation therapy prior to stroke
- •Hypotension
- •Dehydration
- •Hypersalivation
- •Pregnancy, parturients, breast feeding
- •Absence of consent
结局指标
主要结局
CPAP feasibility
时间窗: day 5
Number of patients for which CPAP is used for a minimum of 3 hours per night over 5 nights. CPAP feasibility is retained if at least 50% of all patients have had the use of CPAP for at least 3 hours per night over 5 nights.
次要结局
- Tolerance of CPAP by patient per night(5 nights)
- Number of hypotensive episodes per night per patient(5 nights)
- Feasibility of the ventilatory polygraph(night 1)