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NCT02163837 Clinical Trial

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

Hepatic Encephalopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02163837
Other study ID # AK/14-02-14/4343
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date July 2015

Study information
Verified date April 2019
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rifaximine

Locations
Country Name City State
Belgium CHU St Pierre Brussels

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Other Quality of Sleep assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality 28 days
Other Total Sleep Time total sleep time/ 24h, measured in minutes, by actigraphy 28 days
Other Number of Steps Walked Daily number of steps walked daily assessed by actigraphy (measure of physical activity) 28 days
Primary Percentage of Slow Wave Sleep and REM Sleep sum of percentage of sleep spent in slow wave sleep and REM sleep during sleep per 24h ; assessed by 24-h polysomnography 28 days
Secondary Sleep Efficiency total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy 28 days
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