Effect of Supplemental Nightly Melatonin on REM Sleep and Cognitive Function in Hepatic Encephalopathy

What this Trial Is About

Researchers are evaluating the effect of melatonin on sleep, cognitive function, and quality of life in patients with cirrhosis who have a complication called hepatic encephalopathy (HE). This pilot study aims to determine whether melatonin increases REM sleep, which is often reduced in cirrhosis, and if it improves cognitive function and quality of life. The study focuses on covert hepatic encephalopathy (CHE), a condition that affects many cirrhosis patients and is linked to cognitive decline and poor sleep. Participants will take two supplements in a randomized, double-blinded, crossover design: one month of 3 mg nightly melatonin and one month of 100 mg nightly thiamine, with a one-week washout period in between. Half of the participants will start with melatonin and then switch to thiamine, while the others will do the reverse. Both supplements are taken 30 to 60 minutes before bedtime. Sleep will be monitored continuously using a wearable tracker throughout the study, and formal sleep studies plus salivary melatonin collection will be done at the end of each treatment period. Participants will have a two-week baseline sleep assessment before starting the treatment periods. They will undergo cognitive tests, complete surveys about their sleep and quality of life, and have polysomnography sleep studies at about weeks 4 and 9. The researchers will measure changes in REM sleep, total sleep time, deep sleep, sleep efficiency, heart rate during sleep, cognitive performance, and subjective sleep quality. The study will last about 11 weeks for each participant, with close monitoring to assess the effects of melatonin compared to thiamine.

Affect of Melatonin on Sleep and Cognition in Cirrhosis