努力时的大脑:呼吸系统患者缺氧的影响 (NEUROX)
2018年3月5日 更新者:University Hospital, Grenoble
脑氧合由 CaO2 和脑血流量 (CBF) 的乘积决定,其中之一的改变会影响神经元 O2 的可用性。
除了 PaO2 的影响外,CBF 还受 PaCO2 的调节。 在缺氧状态下,PaO2 的下降与 PaCO2 的潜在下降相关,因此 CBF 可能会在大脑 O2 的需求和供应之间产生重要的头晕。
似乎缺氧会严重影响中枢神经元的反应,就像运动皮层的产生产生运动命令一样。
研究表明,在严重缺氧条件下运动会对大脑氧合和运动命令构成必要威胁,从而导致运动表现下降。
该项目旨在研究缺氧对慢性呼吸系统疾病患者大脑功能的影响。 大脑在休息或运动时的神经生理反应,包括滴注和脑氧合、皮层兴奋和运动命令,这些反应是在治疗前后导致缺氧受试者纠正血液中的气体异常。
该研究将使用多学科和补充方法:近红外光谱 (NIRS) 来评估点滴和脑氧合、CBF、神经刺激程序和肌电图 (EMG) 来评估皮质兴奋性、测量中枢激活和运动水平命令。
这项研究的目标是:
- 与健康对照受试者相比,测量滴注和脑氧合、皮质兴奋性、自愿激活机制和中枢疲劳对慢性低氧血症患者的努力。
- 分析运动参数和姿势图的中断,在简单和双重任务中,涉及不同级别的大脑任务。
- 分析改善慢性阻塞性肺疾病 (COPD) 患者动脉氧合对滴注和脑氧合、皮质兴奋性、自主激活机制和中枢疲劳的急性影响。
- 评估持续气道正压通气 (CPAP) 对患有具有相同参数的阻塞性睡眠呼吸暂停 (OSA) 患者的治疗效果。
研究概览
研究类型
介入性
注册 (实际的)
33
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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La Tronche、法国、38700
- UniversityHospitalGrenoble
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、OLDER_ADULT)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准:
慢阻肺患者
- GOLD III - IV 期,FEV1/FVC 比率 < 0.7 和最大自主通气量 (MVV) < 预测值的 50%
- 体重指数 < 30 公斤/平方米
- 年龄在 18 至 80 岁之间
- 非吸烟者或戒烟者(戒烟超过 3 个月)
- 3个多月以来病情稳定
- PaCO2 < 45 mmHg 在环境空气中休息
- 无 OSA 诊断
阻塞性睡眠呼吸暂停患者
- 最近诊断出严重的 OSA(呼吸暂停低通气指数 (AHI) > 30)
- Epworth 嗜睡量表 (ESS) 得分 > 10
- 年龄在 18 至 80 岁之间
- 体重指数 < 30 公斤/平方米
控制对象
- 年龄在 18 至 80 岁之间
- 体重指数 < 30 公斤/平方米
- 非吸烟者
- 无任何慢性呼吸道疾病、心血管、代谢、肾脏或神经肌肉、前庭和/或视力障碍
排除标准:
OSA 和 COPD 患者
- 病理心血管、神经肌肉、代谢、肾脏
- 酗酒
- 体重指数 > 30 公斤/平方米
- 精神障碍或行为障碍史、视力障碍、前庭障碍、对破坏姿势控制和行走敏感的神经系统疾病、认知障碍
- 不到 3 个月不稳定
- 反对应用外部磁场的论据
控制对象
- 呼吸系统疾病、心血管、神经肌肉、代谢、肾脏
- 酗酒
- 体重指数 > 30 公斤/平方米
- 精神障碍或行为障碍史
- 反对应用外部磁场的论据
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础_科学
- 分配:随机化
- 介入模型:平行线
- 屏蔽:没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
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ACTIVE_COMPARATOR:慢性阻塞性肺疾病 (COPD)
18位患者
|
达到最大有氧能力的 80%,直到筋疲力尽
直到筋疲力尽
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ACTIVE_COMPARATOR:阻塞性睡眠呼吸暂停 (OSA)
18位患者
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达到最大有氧能力的 80%,直到筋疲力尽
直到筋疲力尽
|
ACTIVE_COMPARATOR:健康志愿者
36名对照患者
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达到最大有氧能力的 80%,直到筋疲力尽
直到筋疲力尽
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
近红外光谱 (NIRS)
大体时间:半小时
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肌肉和大脑水平的总脱氧血红蛋白和血红蛋白的数量,同时休息或努力响应吸入不同比例的 O2 和 CO2。
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半小时
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Patrick Levy, Professor、Grenoble Hospital University
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年6月1日
初级完成 (实际的)
2016年4月1日
研究完成 (实际的)
2018年3月1日
研究注册日期
首次提交
2016年7月26日
首先提交符合 QC 标准的
2016年8月2日
首次发布 (估计)
2016年8月3日
研究记录更新
最后更新发布 (实际的)
2018年3月7日
上次提交的符合 QC 标准的更新
2018年3月5日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.