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

NCT02163837 | Completed Results

• 1 other identifier: AK/14-02-14/4343
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Keywords

sleep quality; physical activity; daytime sleepiness; actigraphy; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sleep Efficiency

  28 days

Other Outcomes (3)

• Quality of Sleep

  28 days

• Total Sleep Time

  28 days

• Number of Steps Walked Daily

  28 days

Study Arms (1)

rifaximine

EXPERIMENTAL

Drug: rifaximine

Interventions

rifaximine DRUG

Also known as: Targaxan

rifaximine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18y hepatic encephalopathy: positive Conn score

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU St Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Sleep Initiation and Maintenance Disorders; Motor Activity; Disorders of Excessive Somnolence

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr Marie Bruyneel
• Organization: Chu St Pierre

marie_bruyneel@stpierre-bru.be

003225354219

Study Officials

• Marie Bruyneel, MD

  CHU St Pierre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef de clinique

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 16, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 1, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-04

Locations

BE (1)