Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
AutoSop-Foie
1 other identifier
interventional
55
1 country
1
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 driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers supervision, virtual reality, pharmacology) among the "RĂ©seau Eveil Sommeil Attention et Transports" (RESAT) network.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 4, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 27, 2013
February 1, 2013
2.8 years
October 4, 2010
February 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep latency during Maintenance of Wakefulness Test (MWT)
40 min
Secondary Outcomes (2)
Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG).
1 night
Nocturnal sleep quality and quantity measured by Actimetry.
during 3 days
Study Arms (2)
Carnitine
EXPERIMENTALVersus placebo.
Lactulose
EXPERIMENTALVersus placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Caen
Caen, 14033, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Astrid PIQUET
University Hospital, Caen
- STUDY DIRECTOR
Thong DAO
University Hospital, Caen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2010
First Posted
November 1, 2010
Study Start
September 1, 2009
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
February 27, 2013
Record last verified: 2013-02