Development of Tools for Respiration and Circulation Studies and Exploration, Their Mutual Interactions and the Functions Involved in the Daily Life in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Feasibility and use of developed methods and tools in clinical or fundamental research protocols or in systems for physiological monitoring in humans
研究概览
简要总结
This study is aimed to develop analysis methods and measurements tools for physiological variables : respiration, circulation and their mutual interactions and with the functions involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...). The devices that are used are non invasive. The development of these tools needs to be validated on physiological signals obtained in healthy volunteers.
详细描述
The analysis and interpretation of a record consist, for example, to measure the amplitude of the respiratory modulation of the cardiac period, a witness of the level of the subject's sympathetic activity.
To do this, a mathematical model of this oscillation is adjusted on the experimental data, and its characteristics (amplitude, phase, non-linearity...) are considered indexes of the interaction to be compared with the same characteristics in other conditions.
The transition to clinical applications requires validation of the developed tools on physiological signals recorded on healthy volunteers in a non-clinical environment, avoiding extra psychological stress in the Protocol followed.
Whether it is for the development of tools or their validation, it is essential that the sensors used are non-invasive.
Recorded situations are those of everyday life, such as working (only sedentary work are envisaged), eat, talk, rest and move from one place of life to another one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, major and socially insured human subjects
排除标准
- •deprived of liberty, hospitalized and protected human subjects
研究组 & 干预措施
volunteers in daily life activities
a set of wearable respiration and cardiac monitoring devices
干预措施: a set of wearable respiration and cardiac monitoring devices (Device)
结局指标
主要结局
Feasibility and use of developed methods and tools in clinical or fundamental research protocols or in systems for physiological monitoring in humans
时间窗: up to 24 months
The new tools for identification and monitoring of the physiological state of a subject will be developed from a set of non-invasive measures at rest. Resulting physiological state identification will then be validated on registrations on the same subjects in different daily life circumstances.
次要结局
未报告次要终点