Hepatic Encephalopathy
Conditions
Keywords
sleep quality, physical activity, daytime sleepiness, actigraphy, quality of life
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.
Interventions
DRUGrifaximine
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Slow Wave Sleep and REM Sleep | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | 28 days | total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Sleep | 28 days | assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality |
| Total Sleep Time | 28 days | total sleep time/ 24h, measured in minutes, by actigraphy |
| Number of Steps Walked Daily | 28 days | number of steps walked daily assessed by actigraphy (measure of physical activity) |
Countries
Belgium
Participant flow
Pre-assignment details
all participants of this single arm study were actively enrolled
Participants by arm
| Arm | Count |
|---|---|
| Rifaximine rifaximine was given to all included patients after one week of assesment of sleep disturbances by polysomnography, actigraphy and questionnaires | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Rifaximine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rifaximine | Percentage of Slow Wave Sleep and REM Sleep | 56 percentage of total sleep time per 24h | Standard Deviation 16 |
Secondary
Sleep Efficiency
total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rifaximine | Sleep Efficiency | 75 percentage | Standard Deviation 7 |
Other Pre-specified
Number of Steps Walked Daily
number of steps walked daily assessed by actigraphy (measure of physical activity)
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rifaximine | Number of Steps Walked Daily | 905 steps per day |
Comparison: Mc Nemar symetry test for repeated measures and paired t-tests as appropriatedp-value: <0.05McNemar
Other Pre-specified
Quality of Sleep
assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rifaximine | Quality of Sleep | 9 units on a scale | Standard Deviation 5 |
Other Pre-specified
Total Sleep Time
total sleep time/ 24h, measured in minutes, by actigraphy
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rifaximine | Total Sleep Time | 446 minutes |