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

Primary Purpose

Hepatic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
rifaximine
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring sleep quality, physical activity, daytime sleepiness, actigraphy, quality of life

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU St Pierre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rifaximine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sleep Efficiency
total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy

Full Information

First Posted
June 6, 2014
Last Updated
April 17, 2019
Sponsor
Centre Hospitalier Universitaire Saint Pierre
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1. Study Identification

Unique Protocol Identification Number
NCT02163837
Brief Title
Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
sleep quality, physical activity, daytime sleepiness, actigraphy, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bruyneel, MD
Organizational Affiliation
CHU St Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU St Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

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

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