Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- NIHSS change from the baseline to 3 months
研究概览
简要总结
This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation.
The study will enroll 140 subjects which will be randomized into one of two arms:
- Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge.
- Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
详细描述
Patients eligible to be enrolled in this study are patients admitted to the Department of Neurology due to acute ischemic stroke up to 72 hours from the start of the stroke symptoms.
After receiving written informed consent from the patient, patients will be randomized into the intervention and control groups (1:1). The intervention group will be tested for sleep apnea and C-PAP treatment will be initiated during the initial hospitalization. The control group will receive standard medical care. Control group patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
All subjects:
- At the baseline, physical examination MRS and NIHSS will be performed by the neurologist.
- Sleep testing at the baseline with mobile sleep lab device (Watch PAT)
- Four questionnaires will be administered for all patients: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), quality of life (SF36), depression scale (Beck).
- Blood sample will be taken for CRP, TNF-alpha, IL-6 and IL1 beta, VEGF, HBA1C, LDL and markers of endothelial dysfunction. These blood tests will be repeated at 3 and 6 months.
- At discharge from the Neurology Department, 3 months and 6 months all patients will undergo NIHSS assessment.
- Patients will be referred to the Soroka stroke clinic with rehabilitation program.
- All patients will undergo 3 brain MRI scans, at baseline hospitalization, 3 and 6 months after.
Intervention group:
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
- 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
- •Patients over the age of
- •Admitted to the Neurology Department due to acute ischemic stroke.
- •Able to sign informed consent.
- •Admission NIHSS 6-12.
排除标准
- •Stroke symptom onset more than 72 hours prior to the enrollment
- •Transient Ischemic Attack.
- •Chronic pulmonary disease requiring home oxygen treatment.
- •History of C-PAP treatment
研究组 & 干预措施
Investigatory 1
The sleep study will be performed via Watchpat during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge for three months.
干预措施: Watchpat (Device)
Investigatory 1
The sleep study will be performed via Watchpat during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge for three months.
干预措施: CPAP (Device)
Investigatory 2
The sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months.
干预措施: Watchpat (Device)
Investigatory 2
The sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months.
干预措施: CPAP (Device)
结局指标
主要结局
NIHSS change from the baseline to 3 months
时间窗: 3 months
Change in the NIHSS score from admission to three months
次要结局
- Change depression scale (Beck) at 3 and 6 months from the baseline(6 months)
- NIHSS score change from admission to 6 months following hospitalization(6 months)
- NIHSS score change from three to six months following hospitalization(6 month)
- Evaluate new MRI ischemic lesions between 3 MRI scans.(6 months)
- Prevent recurrent strokes at 6 months(6 months)
- Change number of severe adverse events (SAE) at 3 months(3 months)
- NIHSS change score from admission to discharge from the Neurology Department.(3 months)
- Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke)(6 months)
- Change Epworth Sleepiness Scale (ESS) at 3 and 6 months from the baseline(6 months)
- Change quality of life (SF36) at 3 and 6 months from the baseline(6 months)
研究者
Gal Ifergane MD
Head of Neurology Department
Soroka University Medical Center