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MedDrive's Responsiveness to Alcohol (OH-MedDrive)

20 aprile 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 40 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Cranberry juice alone
500 mL of cranberry juice
Altro: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Sperimentale: BAC 0.5 g/L
Cranberry juice with ethanol to rise BAC to 0.5 g/L
Altro: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Altro: 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.
Sperimentale: BAC 0.65 g/L
Cranberry juice with ethanol to rise BAC to 0.65 g/L
Altro: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Altro: 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.
Sperimentale: BAC 0.8 g/L
Cranberry juice with ethanol to rise BAC to 0.8 g/L
Altro: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
central visual processing time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Useful Field of View
Lasso di tempo: 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
Lasso di tempo: 1 hour post-intervention
The duration of tasks TMT-A and TMT-B are provided in seconds
1 hour post-intervention
StSoftware driving simulator
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse events
Lasso di tempo: 1 week after intervention
New symptoms, accidents, hospitalisation are recorded one week after each visit.
1 week after intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Lausanne

Collaboratori

University Hospital, Geneva
University of Lausanne Hospitals

Investigatori

  • Investigatore principale: Bernard Favrat, MD, CHUV, University of Lausanne
  • Direttore dello studio: Patrice Mangin, MD, PhD, CHUV, University of Lausanne

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2013

Completamento primario (Effettivo)

1 aprile 2013

Completamento dello studio (Effettivo)

1 aprile 2013

Date di iscrizione allo studio

Primo inviato

28 gennaio 2013

Primo inviato che soddisfa i criteri di controllo qualità

29 gennaio 2013

Primo Inserito (Stima)

31 gennaio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 aprile 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 aprile 2013

Ultimo verificato

1 aprile 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CE-12-277

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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