'Study to Investigate the Effects of an Energy Drink During a 15-minute Break Versus Continued Driving on Driving Performance in the STISIM Driving Simulator'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane
研究概览
简要总结
Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink counteracts driver sleepiness.
Objective: The objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3) continued driving.
Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy human volunteers, 21-35 years old.
Intervention: Each subject performs 3 test days:
- 4 hours continued driving
- 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving
- 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •He/she is aged between 21 and 35 years old
- •BMI between 21 and 30,
- •55-85 kg body weight
- •Non smoker
- •Written informed consent
- •Normal static binocular acuity, corrected or uncorrected
- •Normal hearing
- •Possession of a valid driver's license for at least 3 years
- •Regular driver (> 5000 km / year)
- •Be considered as reliable and mentally capable of adhering to the protocol.
排除标准
- •Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test
- •Use of psychoactive medication
- •Pregnancy
- •Positive alcohol breath test
- •Prior enrolment in the same study
- •Physical or mental illness
- •Excessive alcohol use (>21 alcoholic drinks per week)
- •Intake of caffeine-containing beverages under 2 or over 4 glasses per day
- •Regular consumption of Energy Drinks (>1 per month)
- •Shift worker (or no regular sleep pattern)
- •Epworth Sleepiness Score (ESS) > 10
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane
时间窗: the 2 hours of driving following the intervention
次要结局
- Number of collisions(the 2 hours of driving following the intervention)