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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Armodafinil; Modafinil

Criteria

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.