Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. (AutoSop-Foie)
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
L-carnitine
Lactulose
Sponsored by

About this trial
This is an interventional prevention trial for Cirrhosis focused on measuring sleep, cirrhosis, encephalopathy, simulated driving, sleep disorders
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University Hospital of Caen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Carnitine
Lactulose
Arm Description
Versus placebo.
Versus placebo
Outcomes
Primary Outcome Measures
Sleep latency during Maintenance of Wakefulness Test (MWT)
Secondary Outcome Measures
Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG).
Nocturnal sleep quality and quantity measured by Actimetry.
Full Information
NCT ID
NCT01231828
First Posted
October 4, 2010
Last Updated
February 26, 2013
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT01231828
Brief Title
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
Acronym
AutoSop-Foie
Official Title
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 "Réseau Eveil Sommeil Attention et Transports" (RESAT) network.
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) regulating fitness to drive, the Maintenance of Wakefulness Test (MWT) is now mandatory to evaluate driving skills of patients suffering of excessive daytime sleepiness. The MWT has shown a good predictability of driving handicap on simulators in patients suffering from obstructive sleep apnea syndrome. Nevertheless no study has proven yet the predictability of the MWT regarding real and simulated driving in patients suffering from hepatic encephalopathy. Furthermore, even if therapeutic drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. Lactulose, a treatment of hepatic encephalopathy, has not been tested as a counter measure to driving impairment. This lack of knowledge is a major handicap to evaluate driving skills of treated patients suffering from excessive daytime sleepiness. The main objective of our project is to test the predictive value of the MWT on real and simulated driving performances in untreated and treated sleepy patients suffering from hepatic encephalopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
sleep, cirrhosis, encephalopathy, simulated driving, sleep disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carnitine
Arm Type
Experimental
Arm Description
Versus placebo.
Arm Title
Lactulose
Arm Type
Experimental
Arm Description
Versus placebo
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Other Intervention Name(s)
Levocarnil.
Intervention Description
L-carnitine 4g per day (4 bottles of 10ml).
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Duphalac.
Intervention Description
Lactulose (30-60 ml per day)
Primary Outcome Measure Information:
Title
Sleep latency during Maintenance of Wakefulness Test (MWT)
Time Frame
40 min
Secondary Outcome Measure Information:
Title
Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG).
Time Frame
1 night
Title
Nocturnal sleep quality and quantity measured by Actimetry.
Time Frame
during 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Astrid PIQUET
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thong DAO
Organizational Affiliation
University Hospital, Caen
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Caen
City
Caen
ZIP/Postal Code
14033
Country
France
12. IPD Sharing Statement
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Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
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