Trial Outcomes & Findings for Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy (NCT NCT02163837)

NCT ID: NCT02163837

Last Updated: 2019-05-01

Results Overview

sum of percentage of sleep spent in slow wave sleep and REM sleep during sleep per 24h ; assessed by 24-h polysomnography

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2019-05-01

Participant Flow

all participants of this single arm study were actively enrolled

Participant milestones

Measure	Rifaximine rifaximine was given to all included patients after one week of assesment of sleep disturbances by polysomnography, actigraphy and questionnaires
Before Rifaximin STARTED	15
Before Rifaximin COMPLETED	15
Before Rifaximin NOT COMPLETED	0
Day 28 of Rifaximin Treatment STARTED	15
Day 28 of Rifaximin Treatment COMPLETED	15
Day 28 of Rifaximin Treatment NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Rifaximine n=15 Participants rifaximine was given to all included patients after one week of assesment of sleep disturbances by polysomnography, actigraphy and questionnaires
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

sum of percentage of sleep spent in slow wave sleep and REM sleep during sleep per 24h ; assessed by 24-h polysomnography

Outcome measures

Measure	Rifaximine n=15 Participants rifaximine
Percentage of Slow Wave Sleep and REM Sleep	56 percentage of total sleep time per 24h Standard Deviation 16

SECONDARY outcome

Timeframe: 28 days

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

Outcome measures

Measure	Rifaximine n=15 Participants rifaximine
Sleep Efficiency	75 percentage Standard Deviation 7

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality

Outcome measures

Measure	Rifaximine n=15 Participants rifaximine
Quality of Sleep	9 units on a scale Standard Deviation 5

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

total sleep time/ 24h, measured in minutes, by actigraphy

Outcome measures

Measure	Rifaximine n=15 Participants rifaximine
Total Sleep Time	446 minutes Interval 53.0 to 701.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

number of steps walked daily assessed by actigraphy (measure of physical activity)

Outcome measures

Measure	Rifaximine n=15 Participants rifaximine
Number of Steps Walked Daily	905 steps per day Interval 56.0 to 5498.0

Adverse Events

Rifaximine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Marie Bruyneel

Chu St Pierre

Phone: 003225354219

Email: marie_bruyneel@stpierre-bru.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place