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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00916253
First received: May 29, 2009
Last updated: April 24, 2013
Last verified: April 2013

May 29, 2009
April 24, 2013
March 2010
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00916253 on ClinicalTrials.gov Archive Site
  • Subjective sleepiness (Karolinska and VAS scales) [ Time Frame: for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subjective sleepiness (Karolinska and VAS scales) [ Time Frame: for each condition, at day 4 and 5 ] [ Designated as safety issue: No ]
  • nocturnal sleep quality and quantity will be measured by PSG and Actimetry. [ Time Frame: For each condition, at day 4 and 5 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
  • Narcolepsy
  • Hypersomnia
  • 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: Modafinil First
    Treatment by Modafinil during first condition then placebo during second condition
    Interventions:
    • Drug: Modafinil
    • Drug: Placebo
  • Experimental: Placebo First
    Treatment by Placebo during first condition then Modafinil during second condition
    Interventions:
    • Drug: Modafinil
    • Drug: Placebo
  • No Intervention: H
    Healthy Volunteers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00916253
CHUBX 2008/37
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Pierre PHILIP, MD, PHD University Hospital, Bordeaux
University Hospital, Bordeaux
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP