MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- EEG data collected by head phone like EEG electrodes developed by NaoX Technologies
研究概览
简要总结
To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.
详细描述
Objective and primary endpoint:
Demonstrate that the NaoX measurement tool detects sleep deprivation in medical residents performing medical shifts.
The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.
The data analysis will be blinded to the measurement.
Secondary endpoints and objectives :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 volunteers.
- •Male, female.
- •Medical residents.
- •Aged between 24 and 34 years.
- •Doing emergency, intensive care or "inside" shifts.
- •Working in a health institution.
- •No history of epilepsy.
- •No background treatment that could have an impact on the EEG (electroencephalogram) data (type: benzodiazepines, anti-epileptics).
- •No significant change in background treatment during the study, if any.
- •Affiliation to the social security system.
- •Informed volunteer who has signed a consent form.
排除标准
- 未提供
研究组 & 干预措施
volunteers
Health volunteers
干预措施: NaoX Intra-Auricular Device (IAD) monitoring EEG data (Device)
volunteers
Health volunteers
干预措施: Simple psychometric tests (Behavioral)
结局指标
主要结局
EEG data collected by head phone like EEG electrodes developed by NaoX Technologies
时间窗: through study completion, an average of 12 hours
Demonstrate that the NaoX head phone like EEG electrodes detects sleep deprivation in medical residents performing medical shifts. The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements. The data analysis will be blinded to the measurement.
次要结局
- Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX head phone like EEG electrodes tool and the state of fatigue experienced(through study completion, an average of 12 hours)
- Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests(through study completion, an average of 12 hours)