- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01781273
MedDrive's Responsiveness to Alcohol (OH-MedDrive)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Geneva
-
Geneva 4, Geneva, Suisse, 1211
- Institute of Legal Medicine, University of Geneva
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Cranberry juice alone
500 mL of cranberry juice
|
100 mL cranberry juice is provided in a 250 ml container.
|
Expérimental: BAC 0.5 g/L
Cranberry juice with ethanol to rise BAC to 0.5 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.
|
Expérimental: 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.
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
central visual processing time
Délai: 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.
|
1 hour post-intervention
|
peripheral visual processing time
Délai: 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.
|
1 hour post-intervention
|
dual task processing time
Délai: 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.
|
1 hour post-intervention
|
neutral response time
Délai: 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.
|
1 hour post-intervention
|
conditioned alerting gain
Délai: 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.
|
1 hour post-intervention
|
orientation gain
Délai: 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.
|
1 hour post-intervention
|
attention shift response time
Délai: 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.
|
1 hour post-intervention
|
distance to first cue
Délai: 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.
|
1 hour post-intervention
|
distance to last cue
Délai: 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.
|
1 hour post-intervention
|
spatial resolution decay
Délai: 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).
|
1 hour post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Useful Field of View
Délai: 1 hour post-intervention
|
The UFOV is a neuropsychological task which provides four outputs: visual processing, divided attention, selective attention, and overall risk
|
1 hour post-intervention
|
Trial Making Task
Délai: 1 hour post-intervention
|
The duration of tasks TMT-A and TMT-B are provided in seconds
|
1 hour post-intervention
|
StSoftware driving simulator
Délai: 1 hour post-intervention
|
Standard lateral deviation from the center of the road during the road tracking task, and gain and delay during the car following tasks
|
1 hour post-intervention
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adverse events
Délai: 1 week after intervention
|
New symptoms, accidents, hospitalisation are recorded one week after each visit.
|
1 week after intervention
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bernard Favrat, MD, CHUV, University of Lausanne
- Directeur d'études: Patrice Mangin, MD, PhD, CHUV, University of Lausanne
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CE-12-277
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