Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies (AUTOSOP)

April 24, 2013 updated by: University Hospital, Bordeaux

Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.

The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil Attention Transport). It will stimulate data acquisition in technological research to better understand the difference between real and simulated driving

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Excessive daytime sleepiness is responsible of 20% of traffic accidents and 2/3 of truck accidents on French Freeways. Since the publication of a new law (arrêté du 28 décembre 2005 du journal officiel) regulating fitness to drive, the Maintenance of Wakefulness Test (MWT) is now mandatory to evaluate driving skills of patients suffering of excessive daytime sleepiness. The MWT has shown a good predictability of driving handicap on simulators in patients suffering from obstructive sleep apnea syndrome. Nevertheless no study has proven yet the predictability of the MWT regarding real and simulated driving in narcoleptics and hypersomniacs. Furthermore, even if alerting drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. This lack of knowledge is a major handicap to evaluate driving skills of treated patients suffering from excessive daytime sleepiness. The main objective of our project is to test the predictive value of the MWT on real and simulated driving performances in untreated and treated sleepy patients suffering from narcolepsy and hypersomnia. Inclusion of healthy volunteers will allow to collect reference data about somnolence during MWT.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • GENNPHASS - CHU de Bordeaux
      • Paris, France, 75181
        • AP-HP - Hôpital de l'Hôtel-Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for Patients:

  • Narcoleptic patients with or without cataplexy or hypersomniacs
  • aged from 18 to 65 years,
  • treated for attacks of cataplexy,
  • treated with a maximum dose of Modiodal: 400 mg per day (4 tablets of 100mg),
  • without any other disease which could be responsible of excessive daytime sleepiness,
  • having their driver's licence,
  • driving more than 5000 Km/year,
  • registered to French national health and pensions organization,
  • having regular timetables of life 7 days before beginning the study,
  • having given their written light agreement in order to participate in the study.

Inclusion Criteria for Healthy Volunteers:

  • without any sleep disorders,
  • having their driver's licence since at least 2 years,
  • driving more than 5000 Km/year,
  • registered to French national health and pensions organization,
  • having regular timetables of life 7 days before beginning the study,
  • having given their written light agreement in order to participate in the study.

Exclusion Criteria for Patients:

  • Night workers,
  • breast-feeding or pregnant women
  • Beck's scale score < 8,
  • neurologic disease,
  • cardiovascular disorders including cardiac arrhythmia,
  • sleep disorders except narcolepsy and hypersomnia,
  • pulmonary disorders,
  • renal disorders,
  • endocrinal disorders,
  • having participated in a clinical study during the last 6 months,
  • unable to drive.

Exclusion Criteria for Healthy Volunteers:

  • Night workers,
  • neurologic disease,
  • cardiovascular disorders,
  • sleep disorders,
  • pulmonary disorders,
  • renal disorders,
  • endocrinal disorders,
  • having participated in a clinical study during the last 6 months,
  • unable to drive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modafinil First
Treatment by Modafinil during first condition then placebo during second condition
Drug: Modafinil

Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).
Drug: Placebo

Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
Experimental: Placebo First
Treatment by Placebo during first condition then Modafinil during second condition
Drug: Modafinil

Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).
Drug: Placebo

Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
No Intervention: H
Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road
Time Frame: for each condition, at day 4 for patients or day 1 for healthy volonteers
for each condition, at day 4 for patients or day 1 for healthy volonteers

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective sleepiness (Karolinska and VAS scales)
Time Frame: for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers
for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers
nocturnal sleep quality and quantity will be measured by PSG and Actimetry.
Time Frame: For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers
For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Pierre PHILIP, MD, PHD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2008/37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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