Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

MedDrive's Responsiveness to Alcohol (OH-MedDrive)

20. April 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

21

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Cranberry juice alone
500 mL of cranberry juice
Sonstiges: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Experimental: BAC 0.5 g/L
Cranberry juice with ethanol to rise BAC to 0.5 g/L
Sonstiges: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Sonstiges: 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.
Experimental: BAC 0.65 g/L
Cranberry juice with ethanol to rise BAC to 0.65 g/L
Sonstiges: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Sonstiges: 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.
Experimental: BAC 0.8 g/L
Cranberry juice with ethanol to rise BAC to 0.8 g/L
Sonstiges: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
central visual processing time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Useful Field of View
Zeitfenster: 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
Zeitfenster: 1 hour post-intervention
The duration of tasks TMT-A and TMT-B are provided in seconds
1 hour post-intervention
StSoftware driving simulator
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adverse events
Zeitfenster: 1 week after intervention
New symptoms, accidents, hospitalisation are recorded one week after each visit.
1 week after intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Lausanne

Mitarbeiter

University Hospital, Geneva
University of Lausanne Hospitals

Ermittler

  • Hauptermittler: Bernard Favrat, MD, CHUV, University of Lausanne
  • Studienleiter: Patrice Mangin, MD, PhD, CHUV, University of Lausanne

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2013

Primärer Abschluss (Tatsächlich)

1. April 2013

Studienabschluss (Tatsächlich)

1. April 2013

Studienanmeldedaten

Zuerst eingereicht

28. Januar 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Januar 2013

Zuerst gepostet (Schätzen)

31. Januar 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. April 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. April 2013

Zuletzt verifiziert

1. April 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CE-12-277

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Cranberry juice

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Malaysia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren