MedDrive's Responsiveness to Alcohol (OH-MedDrive)
2013年4月20日 更新者：Bernard Favrat, MD、University of Lausanne
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Geneva
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Geneva 4、Geneva、瑞士、1211
- Institute of Legal Medicine, University of Geneva
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Cranberry juice alone
500 mL of cranberry juice
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100 mL cranberry juice is provided in a 250 ml container.
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实验性的：BAC 0.5 g/L
Cranberry juice with ethanol to rise BAC to 0.5 g/L
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100 mL cranberry juice is provided in a 250 ml container.
During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes.
Depending of the allocation, these drinks will contain more or less alcohol.
Pure ethanol will be used mixed with the beverage.
The amount of alcohol to dilute in the drink will be calculated using Widmarks formula.
Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml.
To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol.
The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.
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实验性的：BAC 0.65 g/L
Cranberry juice with ethanol to rise BAC to 0.65 g/L
|
100 mL cranberry juice is provided in a 250 ml container.
During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes.
Depending of the allocation, these drinks will contain more or less alcohol.
Pure ethanol will be used mixed with the beverage.
The amount of alcohol to dilute in the drink will be calculated using Widmarks formula.
Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml.
To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol.
The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.
|
|
实验性的：BAC 0.8 g/L
Cranberry juice with ethanol to rise BAC to 0.8 g/L
|
100 mL cranberry juice is provided in a 250 ml container.
During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes.
Depending of the allocation, these drinks will contain more or less alcohol.
Pure ethanol will be used mixed with the beverage.
The amount of alcohol to dilute in the drink will be calculated using Widmarks formula.
Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml.
To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol.
The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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central visual processing time
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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peripheral visual processing time
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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dual task processing time
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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neutral response time
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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conditioned alerting gain
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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orientation gain
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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attention shift response time
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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distance to first cue
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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distance to last cue
大体时间：1 hour post-intervention
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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.
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1 hour post-intervention
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spatial resolution decay
大体时间：1 hour post-intervention
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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).
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1 hour post-intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Useful Field of View
大体时间：1 hour post-intervention
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The UFOV is a neuropsychological task which provides four outputs: visual processing, divided attention, selective attention, and overall risk
|
1 hour post-intervention
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Trial Making Task
大体时间：1 hour post-intervention
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The duration of tasks TMT-A and TMT-B are provided in seconds
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1 hour post-intervention
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StSoftware driving simulator
大体时间：1 hour post-intervention
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Standard lateral deviation from the center of the road during the road tracking task, and gain and delay during the car following tasks
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1 hour post-intervention
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse events
大体时间：1 week after intervention
|
New symptoms, accidents, hospitalisation are recorded one week after each visit.
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1 week after intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bernard Favrat, MD、CHUV, University of Lausanne
- 研究主任：Patrice Mangin, MD, PhD、CHUV, University of Lausanne
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年2月1日
初级完成 (实际的)
2013年4月1日
研究完成 (实际的)
2013年4月1日
研究注册日期
首次提交
2013年1月28日
首先提交符合 QC 标准的
2013年1月29日
首次发布 (估计)
2013年1月31日
研究记录更新
最后更新发布 (估计)
2013年4月23日
上次提交的符合 QC 标准的更新
2013年4月20日
最后验证
2013年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.