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Completed

NCT Number: NCT00916253

Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies

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

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Key information

Conditions

Narcolepsy Disorders of Excessive Somnolence Dyssomnias Hypersomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GENNPHASS - CHU de Bordeaux, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modafinil

Drug

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).

Placebo

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Subjective sleepiness (Karolinska and VAS scales)

    Time frame: for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: AUTOSOP

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 9, 2009
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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