Affect of Melatonin on Sleep and Cognition in Cirrhosis

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether melatonin, a natural sleep aid, can help improve sleep, thinking skills, and overall quality of life in people with cirrhosis, a liver condition that can cause sleep problems and a brain-related complication called hepatic encephalopathy (HE). The study wants to see if melatonin can increase REM sleep, which is an important and restful part of sleep that is often reduced in people with cirrhosis, and if it can help with mental function and daily well-being.

Adults with cirrhosis who have signs of HE and trouble sleeping may be eligible to join. Participants need to have a smartphone to use a sleep-tracking app and should not regularly use melatonin or have other serious sleep disorders. During the study, participants will take melatonin for one month and then another supplement called thiamine for one month, but neither they nor the researchers will know the order (this is to fairly compare the effects). They will wear a sleep tracker, complete thinking tests and surveys, and have formal sleep studies at a sleep center. This study is not yet recruiting, but it aims to better understand how melatonin might help people with cirrhosis sleep and feel better.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cirrhosis with clinically significant portal hypertension or decompensation defined by Baveno VII criteria \[de Franchis R et al 2022\]
• • Adults over age 18
• • CHE (defined by PHES≤ -4) or previously diagnosed HE
• • Disturbed sleep, with Pittsburgh Sleep Quality Index (PSQI) ≥5
• • Possession of a "smart phone" with Bluetooth capability and ability to download the Oura application (Apple iOS version 14.0 or greater or Android version 8.0 or higher)
• Exclusion Criteria:
• • Use of melatonin regularly (3x per week) if unable/unwilling to discontinue for the study
• • Inability provide informed consent
• • Heavy current alcohol use (\>7 drinks weekly for women and 14 drinks weekly for men)'
• • -- Body mass index \>40
• • Known prior sleep disorder including obstructive sleep apnea
• • Use of other prescription neuromodulating sleep aides
• • Self-reported pregnancy during study screening, as sleep physiology is different in this population