CirrhosisAutoSop-FoieNCT01231828
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
A study testing L-carnitine and Lactulose in people with Cirrhosis, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- L-carnitine and Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Night workers
- neurologic disease
- recent strong complication (< 30 days)
- recent antibiotics or lactulose intake
- substance abusers (alcohol)
- hepatoma more than 5 cm
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.
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.
Read the 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.
- Conditions
- Cirrhosis
- Being tested
- L-carnitine, Lactulose
- Keywords
- sleep, cirrhosis, encephalopathy, simulated driving, sleep disorders
- Medical subject headings
- Fibrosis, Brain Diseases, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDrug
Also called Levocarnil.
L-carnitine 4g per day (4 bottles of 10ml).
LactuloseDrug
Also called Duphalac.
Lactulose (30-60 ml per day)
| Study group | Role | What they receive |
|---|---|---|
| Carnitine | Experimental | Versus placebo. Receives: Drug: L-carnitine |
| Lactulose | Experimental | Versus placebo Receives: Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep latency during Maintenance of Wakefulness Test (MWT)
Measured: 40 min
Secondary outcomes (2)
Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG).
Measured: 1 night
Nocturnal sleep quality and quantity measured by Actimetry.
Measured: during 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Astrid PIQUET, Principal investigator, University Hospital, CaenThong DAO, Study director, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231828
- Sponsor's protocol ID
- A90591-34
- Acronym
- AutoSop-Foie
- Status last verified
- Feb 2013
- First submitted
- 4 Oct 2010
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.
- ClinicalTrials.gov ID
- NCT01231828
- Acronym / sponsor ID
- AutoSop-Foie / A90591-34
- Conditions
- Cirrhosis
- Keywords
- sleep, cirrhosis, encephalopathy, simulated driving, sleep disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carnitine | Experimental | Drug: L-carnitineVersus placebo. |
| Lactulose | Experimental | Drug: LactuloseVersus placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- Night workers
- neurologic disease
- recent strong complication (< 30 days)
- recent antibiotics or lactulose intake
- substance abusers (alcohol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitineAlso: Levocarnil.L-carnitine 4g per day (4 bottles of 10ml). | Drug | Carnitine |
| LactuloseAlso: Duphalac.Lactulose (30-60 ml per day) | Drug | Lactulose |
Primary outcome
Sleep latency during Maintenance of Wakefulness Test (MWT)
Time frame: 40 min
2 secondary outcomes
Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG).
Time frame: 1 night
Nocturnal sleep quality and quantity measured by Actimetry.
Time frame: during 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Astrid PIQUET principal investigator
University Hospital, Caen
Thong DAO study director
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine and Lactulose in people with Cirrhosis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep latency during Maintenance of Wakefulness Test (MWT) (time frame: 40 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.