Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. (AutoSop-Foie)
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|ClinicalTrials.gov Identifier: NCT01231828|
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : February 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis||Drug: L-carnitine Drug: Lactulose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||December 2012|
L-carnitine 4g per day (4 bottles of 10ml).
Other Name: Levocarnil.
Lactulose (30-60 ml per day)
Other Name: Duphalac.
- Sleep latency during Maintenance of Wakefulness Test (MWT) [ Time Frame: 40 min ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231828
|University Hospital of Caen|
|Caen, France, 14033|
|Principal Investigator:||Marie-Astrid PIQUET||University Hospital, Caen|
|Study Director:||Thong DAO||University Hospital, Caen|