NCT03278080已完成不适用
Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 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 set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.
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
- 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/m2 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
- •Routinely drink alcohol before bedtime
- •Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
研究组 & 干预措施
driving test
Other
干预措施: Road-tracking test (Other)
driving test
Other
干预措施: Car-following test (Other)
driving test
Other
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)(25 min.)
- Brake Reaction Time (BRT)(15 min.)
研究者
研究点 (1)
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相似试验
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Development of assessment method for driving ability using driving simulator in Healthy volunteers #1Japanese healthy adult male participantsJPRN-jRCT1080223658Taisho Pharmaceutical co., LTD20
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