Status:
COMPLETED
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
Lead Sponsor:
University Hospital, Caen
Conditions:
Cirrhosis
Eligibility:
All Genders
18-80 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 (2005 december 28th - Official Journal) regula...
Eligibility Criteria
Inclusion
- Cirrhosis proved by histologic or clinico-biologics criteria, whatever its severity, its stability defined by a child stable score (variation \< 2 points for the last month) without any other disease which could be responsible of excessive daytime sleepiness
- driver's licence since at least 2 years
- driving more than 2000 Km/year
- registered to French national health and pensions organization
- having given their written light agreement in order to participate in the study.
Exclusion
- Night workers
- neurologic disease
- recent strong complication (\< 30 days)
- recent antibiotics or lactulose intake
- substance abusers (alcohol)
- hepatoma more than 5 cm
- disorder associated which engaged life prognostic in a short time
- glycemia fasted \> 8 mmol/l
- haemoglobin \< 10g/l
- neurologic or psychiatric disorders associated which affect superiors functions,
- hepatic encephalopathy stage 3 or 4
- having participated in a clinical study during the last 6 months
- drugs abusers
- unable to drive.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01231828
Start Date
September 1 2009
End Date
December 1 2012
Last Update
February 27 2013
Active Locations (1)
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1
University Hospital of Caen
Caen, France, 14033