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Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163837
Recruitment Status : Completed
First Posted : June 16, 2014
Results First Posted : April 9, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre

Brief Summary:
Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine, which is currently given to lower blood ammoniac levels.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: rifaximine Not Applicable

Detailed Description:
Hepatic encephalopathy (HE) is a complex neuropsychiatric syndrome related to chronic/acute hepatic failure. Sleep architecture is disturbed in this syndrome, and patients complain mainly of excessive daytime sleepiness and sleep disturbances. Hypothesis to explain these symptoms is, among others, disturbed melatonin metabolism. Few studies have been conducted in order to study sleep disorders during HE, and effect of treatment is unknown. Recently, rifaximine, an oral broad spectrum antibiotic, have been proved to decrease ammoniac production in patients with HE. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: rifaximine Drug: rifaximine
Other Name: Targaxan




Primary Outcome Measures :
  1. Percentage of Slow Wave Sleep and REM Sleep [ Time Frame: 28 days ]
    sum of percentage of sleep spent in slow wave sleep and REM sleep during sleep per 24h ; assessed by 24-h polysomnography


Secondary Outcome Measures :
  1. Sleep Efficiency [ Time Frame: 28 days ]
    total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy


Other Outcome Measures:
  1. Quality of Sleep [ Time Frame: 28 days ]
    assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality

  2. Total Sleep Time [ Time Frame: 28 days ]
    total sleep time/ 24h, measured in minutes, by actigraphy

  3. Number of Steps Walked Daily [ Time Frame: 28 days ]
    number of steps walked daily assessed by actigraphy (measure of physical activity)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18y hepatic encephalopathy: positive Conn score

Exclusion Criteria:

  • <18y pregnancy inability to fulfil questionnaires acute infection unstable clinical condition bone or articular disease resulting in significant disability

Information from the National Library of Medicine

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): NCT02163837


Locations
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Belgium
CHU St Pierre
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Principal Investigator: Marie Bruyneel, MD CHU St Pierre
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Responsible Party: Marie Bruyneel, Chef de clinique, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT02163837    
Other Study ID Numbers: AK/14-02-14/4343
First Posted: June 16, 2014    Key Record Dates
Results First Posted: April 9, 2019
Last Update Posted: May 1, 2019
Last Verified: April 2019
Keywords provided by Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre:
sleep quality
physical activity
daytime sleepiness
actigraphy
quality of life
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents