N/A
N=15
Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Hepatic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT02163837 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Slow Wave Sleep and REM Sleep — 56 percentage of total sleep time per 24h
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rifaximine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Slow Wave Sleep and REM Sleep |
56 | — |
| SECONDARY Sleep Efficiency |
75 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02163837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.