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临床试验/NCT01321229
NCT01321229已完成不适用

Influence of the Sleep Apnea Syndrome on the Functional Recovery After Stroke in a Rehabilitation Unit

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
the variation of the FIM (Functional Independence Measure)

研究概览

简要总结

The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.

详细描述

The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.

Forty-five patients with the average of 58,2 years had been included in this prospective MONOCENTRICAL study. The detection of the sleep respiratory troubles was realised using a nocturnal oxymetry device and measuring the inspiratory flow, gathering the index of apnea-hypopnea.

The NIHSS, the FIM and the FUGL-MEYER scales were used at the moment of inclusion and two months AFTERWORDS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient's or one family member's agreement for participation in the study Being aged over 18 years Stroke history in the past 6 months (ischemic or hemorrhagic) Hospitalisation in PRM department and participation to a rehabilitation program during study Patient belonging to the social security system

排除标准

  • Patient having a sleep apnea syndrome known prior to inclusion Patient presenting a cardiorespiratory INSUFIENCY Patients being INABLE to carry-out the tests or presenting a mental disorder Patients who started already their rehabilitation program before in another PRM center or department

结局指标

主要结局

the variation of the FIM (Functional Independence Measure)

时间窗: at 2 months

defined by the FIM score after 2 months minus the FIM score at the initial moment(T0)

次要结局

  • age(at inclusion)
  • Score NIHSS (National Institute of Health Stroke Score)(at 2 months)
  • BMI (Body Mass Index)(at inclusion)
  • Fugl Meyer Assessment of Motor Recovery after Stroke(at 2 months)
  • Epworth Sleepiness Scale (ESS)(at inclusion)
  • Attention tests(at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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