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MedDrive's Responsiveness to Alcohol (OH-MedDrive)

20 april 2013 bijgewerkt door: 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:

  1. Measures from MedDrive are influenced by alcohol in a dose dependent way.
  2. Effects of alcohol on driving performances are correlated to measures from MedDrive in a dose dependent way.
  3. Within a group of healthy young drivers, MedDrive shows consistent results over repeated measures (ICC≥0.7).
  4. MedDrive models effects of alcohol on driving performances better than does the UFOV or the trial making task.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

21

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Zwitserland
    • Geneva
      • Geneva 4, Geneva, Zwitserland, 1211
        • Institute of Legal Medicine, University of Geneva

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Cranberry juice alone
500 mL of cranberry juice
Ander: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Experimenteel: BAC 0.5 g/L
Cranberry juice with ethanol to rise BAC to 0.5 g/L
Ander: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Ander: Ethanol
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.
Experimenteel: BAC 0.65 g/L
Cranberry juice with ethanol to rise BAC to 0.65 g/L
Ander: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Ander: Ethanol
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.
Experimenteel: BAC 0.8 g/L
Cranberry juice with ethanol to rise BAC to 0.8 g/L
Ander: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Ander: Ethanol
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
central visual processing time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Useful Field of View
Tijdsspanne: 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
Tijdsspanne: 1 hour post-intervention
The duration of tasks TMT-A and TMT-B are provided in seconds
1 hour post-intervention
StSoftware driving simulator
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse events
Tijdsspanne: 1 week after intervention
New symptoms, accidents, hospitalisation are recorded one week after each visit.
1 week after intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Lausanne

Medewerkers

University Hospital, Geneva
University of Lausanne Hospitals

Onderzoekers

  • Hoofdonderzoeker: Bernard Favrat, MD, CHUV, University of Lausanne
  • Studie directeur: Patrice Mangin, MD, PhD, CHUV, University of Lausanne

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2013

Primaire voltooiing (Werkelijk)

1 april 2013

Studie voltooiing (Werkelijk)

1 april 2013

Studieregistratiedata

Eerst ingediend

28 januari 2013

Eerst ingediend dat voldeed aan de QC-criteria

29 januari 2013

Eerst geplaatst (Schatting)

31 januari 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

23 april 2013

Laatste update ingediend die voldeed aan QC-criteria

20 april 2013

Laatst geverifieerd

1 april 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CE-12-277

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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