CompletedNot Applicable

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

France27 participantsStarted 2010-03

Plain-language 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, * cardiovasc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road

Timeframe: for each condition, at day 4 for patients or day 1 for healthy volonteers

Trial details

NCT IDNCT00916253

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07

View on ClinicalTrials.gov More Narcolepsy trials