Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3: Alcohol Calibration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Standard Deviation of Lateral Position (SDLP)
研究概览
简要总结
The purpose of this study is to collect alcohol calibration data for the driving simulator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection
- •No visual impairment (enable to correct the vision with eyeglasses or contact lens)
- •Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study
排除标准
- •History of drug and food allergy
- •Alcohol dependence, drug dependence or abnormal drunken (including past history)
- •Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
研究组 & 干预措施
Blood alcohol concentration (BAC) level 0.025 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
干预措施: Road-tracking test (Other)
Blood alcohol concentration (BAC) level 0.025 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
干预措施: Car-following test (Other)
Blood alcohol concentration (BAC) level 0.025 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
干预措施: Harsh-braking test (Other)
BAC level 0.05 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
干预措施: Road-tracking test (Other)
BAC level 0.05 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
干预措施: Car-following test (Other)
BAC level 0.05 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
干预措施: Harsh-braking test (Other)
BAC level 0.09 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
干预措施: Road-tracking test (Other)
BAC level 0.09 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
干预措施: Car-following test (Other)
BAC level 0.09 %
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
干预措施: Harsh-braking test (Other)
BAC level 0 %
Drink beverages containing non alcohol
干预措施: Road-tracking test (Other)
BAC level 0 %
Drink beverages containing non alcohol
干预措施: Car-following test (Other)
BAC level 0 %
Drink beverages containing non alcohol
干预措施: Harsh-braking test (Other)
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP)
时间窗: 60 min
次要结局
- Distance Coefficient of Variation (DCV)(5 min)
- Brake Reaction Time (BRT)(5 min)