Impaired DrivingOH-MedDriveNCT01781273
MedDrive's Responsiveness to Alcohol
A study testing Ethanol and Cranberry juice in people with Impaired Driving, run by University of Lausanne at 1 site in Switzerland.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Driving
- What is being tested?
- Ethanol and Cranberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Legal Medicine, University of Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Impaired Driving
- Being tested
- Ethanol, Cranberry juice
- Keywords
- impaired driving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolOther
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.
Cranberry juiceOther
100 mL cranberry juice is provided in a 250 ml container.
| Study group | Role | What they receive |
|---|---|---|
| Cranberry juice alone | Placebo comparator | 500 mL of cranberry juice Receives: Other: Cranberry juice |
| BAC 0.5 g/L | Experimental | Cranberry juice with ethanol to rise BAC to 0.5 g/L Receives: Other: Ethanol; Other: Cranberry juice |
| BAC 0.65 g/L | Experimental | Cranberry juice with ethanol to rise BAC to 0.65 g/L Receives: Other: Ethanol; Other: Cranberry juice |
| BAC 0.8 g/L | Experimental | Cranberry juice with ethanol to rise BAC to 0.8 g/L Receives: Other: Ethanol; Other: Cranberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
central visual processing time
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.
Measured: 1 hour post-intervention
peripheral visual processing time
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.
Measured: 1 hour post-intervention
dual task processing time
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.
Measured: 1 hour post-intervention
neutral response time
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.
Measured: 1 hour post-intervention
conditioned alerting gain
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.
Measured: 1 hour post-intervention
orientation gain
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.
Measured: 1 hour post-intervention
attention shift response time
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.
Measured: 1 hour post-intervention
distance to first cue
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.
Measured: 1 hour post-intervention
distance to last cue
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.
Measured: 1 hour post-intervention
spatial resolution decay
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).
Measured: 1 hour post-intervention
Secondary outcomes (3)
Useful Field of View
The UFOV is a neuropsychological task which provides four outputs: visual processing, divided attention, selective attention, and overall risk
Measured: 1 hour post-intervention
Trial Making Task
The duration of tasks TMT-A and TMT-B are provided in seconds
Measured: 1 hour post-intervention
StSoftware driving simulator
Standard lateral deviation from the center of the road during the road tracking task, and gain and delay during the car following tasks
Measured: 1 hour post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired DrivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, University Hospital, Geneva
- Responsible party
- Principal investigator, Bernard Favrat, MD, University of Lausanne
- Investigators
- Bernard Favrat, MD, Principal investigator, CHUV, University of LausannePatrice Mangin, MD, PhD, Study director, CHUV, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781273
- Sponsor's protocol ID
- CE-12-277
- Acronym
- OH-MedDrive
- Status last verified
- Apr 2013
- First submitted
- 28 Jan 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01781273
- Acronym / sponsor ID
- OH-MedDrive / CE-12-277
- Conditions
- Impaired Driving
- Keywords
- impaired driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, University Hospital, Geneva
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cranberry juice alone | Placebo comparator | Other: Cranberry juice500 mL of cranberry juice |
| BAC 0.5 g/L | Experimental | Other: Ethanol, Other: Cranberry juiceCranberry juice with ethanol to rise BAC to 0.5 g/L |
| BAC 0.65 g/L | Experimental | Other: Ethanol, Other: Cranberry juiceCranberry juice with ethanol to rise BAC to 0.65 g/L |
| BAC 0.8 g/L | Experimental | Other: Ethanol, Other: Cranberry juiceCranberry juice with ethanol to rise BAC to 0.8 g/L |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolDuring 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. | Other | BAC 0.5 g/L, BAC 0.65 g/L, BAC 0.8 g/L |
| Cranberry juice100 mL cranberry juice is provided in a 250 ml container. | Other | BAC 0.5 g/L, BAC 0.65 g/L, BAC 0.8 g/L, Cranberry juice alone |
Primary outcome
central visual processing time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
3 secondary outcomes
Useful Field of View
Time frame: 1 hour post-intervention
Trial Making Task
Time frame: 1 hour post-intervention
StSoftware driving simulator
Time frame: 1 hour post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Favrat, MD principal investigator
CHUV, University of Lausanne
Patrice Mangin, MD, PhD study director
CHUV, University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol and Cranberry juice in people with Impaired Driving, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central visual processing time (time frame: 1 hour post-intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.