Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rifaximine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rifaximine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Sleep | assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality | 28 days |
| Total Sleep Time | total sleep time/ 24h, measured in minutes, by actigraphy |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie Bruyneel, MD | CHU St Pierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU St Pierre | Brussels | 1000 | Belgium |
all participants of this single arm study were actively enrolled
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximine | rifaximine was given to all included patients after one week of assesment of sleep disturbances by polysomnography, actigraphy and questionnaires |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before Rifaximin |
| |||||||||||||
| Day 28 of Rifaximin Treatment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximine | rifaximine was given to all included patients after one week of assesment of sleep disturbances by polysomnography, actigraphy and questionnaires |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | percentage of total sleep time per 24h | 28 days |
|
|
28 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifaximine | rifaximine | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marie Bruyneel | Chu St Pierre | 003225354219 | marie_bruyneel@stpierre-bru.be |
Not provided
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 28 days |
| Number of Steps Walked Daily | number of steps walked daily assessed by actigraphy (measure of physical activity) | 28 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Sleep Efficiency | total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy | Posted | Mean | Standard Deviation | percentage | 28 days |
|
|
|
| Other Pre-specified | Quality of Sleep | assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
|
|
| Other Pre-specified | Total Sleep Time | total sleep time/ 24h, measured in minutes, by actigraphy | Posted | Median | Full Range | minutes | 28 days |
|
|
|
| Other Pre-specified | Number of Steps Walked Daily | number of steps walked daily assessed by actigraphy (measure of physical activity) | Posted | Median | Full Range | steps per day | 28 days |
|
|
|
|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
Not provided
Not provided
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |