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临床试验/NCT03095729
NCT03095729已完成不适用

Cognitive Consequences of an Activation of the Cortical Drive to Breath

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Score at PASAT (Paced Auditory Serial Addition Test)

研究概览

简要总结

The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.

详细描述

Cognitive capacities are measured on healthy subject submitted to inspiratory threshold loading, patients treated by chronic mechanical ventilation due to suffering Ondine syndrome or amyotrophic lateral sclerosis. The spontaneous breathing is compared to NIV breathing or inspiratory threshold loading.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Adults and non-vulnerable adults
  • Fluent in French

排除标准

  • For patients:
  • Total ventilatory dependency
  • Coexistence of an other respiratory disease
  • Alcohol and /or psychotropic consumption during the last 24 hours
  • One or more episodes of acute respiratory failure during the past 6 months
  • Serious cognitive deficiency or presence of fronto temporal dementia
  • End-stage disease
  • No affiliation to social security
  • For healthy volunteers:
  • Existing respiratory disease
  • Alcohol and /or psychotropes consumption during the last 24 hours
  • Tobacco smoking more than 2 pack-years
  • Sleep deprivation
  • Serious cognitive deficiency
  • No affiliation to social security

结局指标

主要结局

Score at PASAT (Paced Auditory Serial Addition Test)

时间窗: 3 hours

Performances will be assessed by counting the number of good and wrong answers, and comparing it in two conditions : spontaneous breathing (SB) versus inspiratory resistive loading for healthy subjects, and SB versus non invasive ventilation for patients.

次要结局

  • Oxygen saturation changes(3 hours)

研究者

发起方
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
申办方类型
Other
责任方
Sponsor

研究点 (1)

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