MedDrive's Responsiveness to Different Blood Alcohol Concentrations and Concurrent Validity Against Performances on a Driving Simulator; a Phase I, Randomised, Double Blind, Placebo, Dose Response Validation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- central visual processing time
研究概览
简要总结
This four-way, dose-response, crossover, double blind, placebo-controlled, randomised validation study investigates the responsiveness of MedDrive, a computed battery of neuropsychological tasks, to different doses of alcohol.
The following hypothesis are tested:
- Measures from MedDrive are influenced by alcohol in a dose dependent way.
- Effects of alcohol on driving performances are correlated to measures from MedDrive in a dose dependent way.
- Within a group of healthy young drivers, MedDrive shows consistent results over repeated measures (ICC≥0.7).
- MedDrive models effects of alcohol on driving performances better than does the UFOV or the trial making task.
详细描述
Background: There is an increasing need for physicians to advice patients on their fitness to drive. Current guidelines underline the limitations of existing instruments and the poor adaptability of batteries of neuropsychological tests assessing fitness to drive in both experimental and primary care settings. The investigators therefore developed MedDrive, a free, reliable, computer based measuring instrument capable of detecting effects of age and drugs on cognitive functions considered as essential for driving.
Objectives: This study aims to test MedDrive responsiveness to different blood alcohol concentrations (BAC) and validate these measures against performances on a driving simulator. It also aims to measure MedDrive's reliability following repeated measures during the training phase, to compare MedDrive's performances in measuring effects of different BAC against the UFOV, and to model MedDrives measures to predict behaviour on the simulator. Finally, this study also includes a nested experimental study measuring effects of alcohol on attention.
Methods: Using Widmark's formula, 16 healthy young drivers are given cranberry juice with different doses of ethanol to bring their BAC to 0 g/L, 0.5 g/L, 0.65 g/L, and 0.8 g/L. They are blinded to the presence of ethanol by inhaling vapors of ethanol just before drinking. BAC is maintained during the entire experiment by using a breathalyser and administrating drinks throughout the experiment. Three scenarios are planned on a driving simulator (StSoftware PvW-2010), a road tracking task, a car following task, and a car following task including dual tasking using peripheral vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20 to 40 years
- •Obtained drivers license at least 24 months before
- •Fit to drive
- •Consumed at least once six units of a beverage with alcohol at a single occasion during the previous six months
排除标准
- •Under the influence of a medicinal drug affecting their driving performance
- •Suffer from a psychiatric condition affecting driving performances
- •Suffer from simulator sickness
- •Presenting criteria (ICD-10) of alcohol dependence.
- •Pregnant or breastfeeding
- •Intolerant to alcohol defined by having either headaches or digestive disorders for quantities of alcohol that do not seem to bother other people.
结局指标
主要结局
central visual processing time
时间窗: 1 hour post-intervention
Corresponds to the duration of exposure in ms for a 37.5% threshold for correct guesses adjusted for chance for central vision in the Visual Recognition Task (Task 1) in MedDrive.
peripheral visual processing time
时间窗: 1 hour post-intervention
Corresponds to the duration of exposure in ms for a 43.8% threshold for correct guesses adjusted for chance for peripheral vision in the Visual Recognition Task (Task 1) in MedDrive.
dual task processing time
时间窗: 1 hour post-intervention
Corresponds to the duration of exposure in ms for a 48.7% threshold for correct guesses adjusted for chance for simultaneous central and peripheral vision (dual tasking) in the Visual Recognition Task (Task 1) in MedDrive.
neutral response time
时间窗: 1 hour post-intervention
Corresponds to the average response time in ms adjusted for learning effect for participants to respond to a peripheral stimuli during the Central Cue Attention Task (Task 2) in MedDrive.
conditioned alerting gain
时间窗: 1 hour post-intervention
Corresponds to the average gain in response time (ms) over the neutral condition after participants are warned of the imminent exposure to a peripheral stimuli during the Central Cue Attention Task (Task 2) in MedDrive.
orientation gain
时间窗: 1 hour post-intervention
Corresponds to the average gain in response time (ms) over the neutral condition after participants are shown where the peripheral stimuli is to show up during the Central Cue Attention Task (Task 2) in MedDrive.
attention shift response time
时间窗: 1 hour post-intervention
Corresponds to the average response time in ms to detect the orientation of a given moving target during the Movement Detection Task (Task 3) in MedDrive.
distance to first cue
时间窗: 1 hour post-intervention
Corresponds to the geometrical mean of distances in mm between the true location of the first cue and its indicated location during the Memory Decay of Spatial Resolution Task (Task 4) in MedDrive.
distance to last cue
时间窗: 1 hour post-intervention
Corresponds to the geometrical mean of distances in mm between the true location of the last cue and its indicated location during the Memory Decay of Spatial Resolution Task (Task 4) in MedDrive.
spatial resolution decay
时间窗: 1 hour post-intervention
Corresponds to the loss in precision for each extra cue shown during the Memory Decay of Spatial Resolution Task (Task 4) in MedDrive (ln(mm)/cue).
次要结局
- Useful Field of View(1 hour post-intervention)
- Trial Making Task(1 hour post-intervention)
- StSoftware driving simulator(1 hour post-intervention)
研究者
Bernard Favrat, MD
Head of Unit of Traffic Medicine and Psychology, Principle Investigator
University of Lausanne