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临床试验/NCT02854280
NCT02854280
已完成
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Brain During Effort : Effects of Hypoxia With Respiratory Patients

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 33 人2013年6月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Obstructive Pulmonary Disease (COPD)
发起方
University Hospital, Grenoble
入组人数
33
试验地点
1
主要终点
Near-infrared spectroscopy (NIRS)
状态
已完成
最后更新
8年前

概览

简要总结

Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF), the modification of one or the other can affect the neuronal O2 availability.

Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and therefore of the CBF, can create an important dizziness between the demand and the supply of cerebral O2.

It seems that hypoxia can trouble in a significant way the response of central neurons, just as the production of a motor cortex generated motor command.

Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat for brain oxygenation and the motor command, with the consequence a decrease of the exercise performance.

This projects aim to study effects of hypoxia on the brain function for patients suffering from chronic respiratory disease. Neurophysiologic responses of the brain while resting or exercising, including drip and cerebral oxygenation, cortical excitation and motor command resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz in blood.

The study will use a multidisciplinary and supplementary methodological approach : the near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF, neurostimulation procedures and electromyography (EMG) to appreciate the cortical excitability, measure the level of central activation and motor command.

The goals of this study will be :

  • Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of voluntary activation and central fatigue to the effort for the chronic hypoxemic patient compared to healthy control subjects.
  • Analyse disruptions of locomotion parameters and posturographyc, in simple and double task, involving different levels of cerebral task.
  • Analyse acute effects of an improvement of arterial oxygenation for patients suffering from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation, cortical excitability, mechanisms of voluntary activation and central fatigue.
  • Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for patients suffering from obstructive sleep apnea (OSA) with the same parameters.
注册库
clinicaltrials.gov
开始日期
2013年6月
结束日期
2018年3月
最后更新
8年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University Hospital, Grenoble
责任方
Sponsor

入排标准

入选标准

  • COPD patients
  • stages GOLD III - IV, FEV1/FVC ratio \< 0,7 and maximum voluntary ventilation (MVV) \< 50% of predicted values
  • BMI \< 30 kg/m²
  • Age between 18 and 80 years
  • Non-smoking or ex-smoker (stop since more than 3 months)
  • Stable condition since more than 3 months
  • PaCO2 \< 45 mmHg resting with ambiant air
  • No OSA diagnostic
  • OSA patients
  • Severe OSA recently dignosed (apnoea-Hypopnoea Index (AHI) \> 30)

排除标准

  • OSA and COPD patients
  • Pathologies cardiovascular, neuromuscular, métabolic, renal
  • Alcoholism
  • BMI \> 30 kg/m²
  • Psychiatric disorders or history of behavioural disorders, vision disorders, vestibular disorders, neurologic disease sensitive to disrupt the postural control and the walking, cognitive disorders
  • Instability since less than 3 months
  • Counter argument to the application of an external magnetic field
  • Control subjects
  • Respiratory pathologies, cardiovascular, neuromuscular, metabolic, renal
  • Alcoholism

结局指标

主要结局

Near-infrared spectroscopy (NIRS)

时间窗: Half an hour

Quantities of total desoxyhemoglobin and hemoglobin at muscular and cerebral levels while resting or during effort in response to inhalation of variable fractions of O2 and CO2.

研究点 (1)

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