Study of Nightly Melatonin Effects on REM Sleep and Thinking in Adults with Cirrhosis and Hepatic Encephalopathy

What this Trial Is About

Researchers are studying the effects of melatonin on sleep, cognitive function, and quality of life in adults with cirrhosis and hepatic encephalopathy HE. This pilot randomized, double-blinded crossover study aims to determine if melatonin increases REM sleepa vital part of healthy sleep often reduced in cirrhosisand whether it improves cognitive function and quality of life. The study also explores the use of wearable sleep trackers as a practical way to monitor sleep in this population. Participants will take 3 mg of melatonin nightly for one month and 100 mg of thiamine a supplement not expected to impact sleep for another month, separated by a one-week washout period. They will be randomly assigned to start with either melatonin or thiamine. Sleep studies and salivary melatonin measurements will be performed at the end of each supplement period, and continuous sleep monitoring will be done using an Oura ring wearable tracker. During the 11-week study, participants will undergo cognitive testing and complete surveys about their sleep quality and overall well-being. Researchers will measure changes in REM sleep and other sleep parameters using polysomnography and wearable data, as well as assess cognitive performance and quality of life. The study includes safety and adherence monitoring, with all assessments occurring at specific times during the treatment periods.

Affect of Melatonin on Sleep and Cognition in Cirrhosis