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COMPLETED
NCT00916253
NA

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2010-03

Completion Date

2012-08

Last Updated

2026-05-14

Healthy Volunteers

Yes

Interventions

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.

Locations (2)

GENNPHASS - CHU de Bordeaux

Bordeaux, France

AP-HP - Hôpital de l'Hôtel-Dieu

Paris, France