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

Not Applicable

Completed

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: rifaximine

• Registration Number: NCT02163837
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2017-09-08
• Results First Submitted QC: 2019-01-11
• Status Verified: 2019-04
• Results First Posted: 2019-04-09
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rifaximine	rifaximine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Slow Wave Sleep and REM Sleep	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

Name	Time	Method
Sleep Efficiency	28 days	total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy

Trial Locations

Locations (1)

CHU St Pierre; 🇧🇪 Brussels, Belgium