跳至主要内容
临床试验/CTRI/2016/07/007104
CTRI/2016/07/007104已完成不适用

Role of continuous positive airway pressure therapy for sleep disordered breathing in prevention of stroke recurrence and other vascular events and in improvement of neuropsychological outcome- A Prospective longitudinal study.

Department of Science and Technology1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年9月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Their Neurological Out come (By Modified Rankin Scale and Barthel Index.

研究概览

简要总结

The Prevalence of obstructive sleep apnea and sleep disordered breathing in general in patients with stroke has been found to range from 50% to 80%. Recently, SDB has been shown to be an independent risk factor for stroke. However, their is their is little evidence in existing literature  on whether treatment of SDB with CPAP therapy, has any effect on prevention of new vascular events, especially recurrence after stroke. This study being planned to assess if treatment of SDB with CPAP in patients with stroke has any role in prevention of new onset vascular events(cardiac ischemia, infarction, stroke recurrence) or death; and whether it has any role in the neuropsychological or cognitive and neurological outcome following stroke. Our hypothesis is that patients of stroke with SDB can obtain benefit with CPAP therapy as regards occurrence of new vascular events and their neurological outcome. The study is proposed to be randomized control trial conscious patients of stroke evaluated clinically and through a polysomnography, diagnosed to have SDB forming the population under study. One group shall be randomized to CPAP therapy and slandered medical therapy and the other to receive only best medical therapy. The primary end point of the study would be occurrence of new vascular events or death and the secondary end points would be neuropsychological outcome and neurological outcome at 3,6 and 12 months.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients presenting to neurology service, All India Institute of Medical sciences, New Delhi, with history suggestive of first arterial stroke with in 6 weeks from ictus, -and with CT Scan or MRI evidence of the same, -with or without cognitive impairment and -those who do not require life support will be enrolled in the study.

排除标准

  • Patients with previous history of stroke.
  • Patients with history of other neurological illness like Parkinsons disease, Neuro-Infections, Neuromuscular disorders and others.
  • Patients with known sleep disorders apart from sleep disordered breathing.

结局指标

主要结局

Their Neurological Out come (By Modified Rankin Scale and Barthel Index.

时间窗: Three months,Six Months,One Year

Cognitive status.

时间窗: Three months,Six Months,One Year

New Vascular events in form of stroke, Myocardial ischemia or Infarction.

时间窗: Three months,Six Months,One Year

Death.

时间窗: Three months,Six Months,One Year

次要结局

  • Neuropsychological outcome(6 months, one year)

研究者

申办方类型
Government funding agency

研究点 (1)

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