Skip to main content
OpenTrials
Completed

NCT Number: NCT02163837

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Encephalopathy Behavior Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Disorders of Excessive Somnolence Dyssomnias Hepatic Insufficiency Liver Diseases Liver Failure Mental Disorders Metabolic Diseases Motor Activity Nervous System Diseases Nutritional and Metabolic Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU St Pierre

Brussels, 1000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rifaximine

Drug

Other names: Targaxan

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2014
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.