Status:
COMPLETED
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Narcolepsy
Hypersomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
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 officie...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00916253
Start Date
March 1 2010
End Date
August 1 2012
Last Update
April 25 2013
Active Locations (2)
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1
GENNPHASS - CHU de Bordeaux
Bordeaux, France, 33076
2
AP-HP - Hôpital de l'Hôtel-Dieu
Paris, France, 75181