Affect of Melatonin on Sleep and Cognition in Cirrhosis

Recruiting now · Not applicable

Conditions studied: Hepatic Encephalopathy, Covert Hepatic Encephalopathy, Cirrhosis, Sleep Disturbances and Insomnia

In brief

The goal of this clinical trial is to learn the affect of melatonin on sleep, cognitive function, and quality of life (QoL) in patients with cirrhosis and a complication called hepatic encephalopathy (HE). The main questions this study aims to answer are: * Does taking melatonin increase REM sleep, an important part of healthy sleep that is reduced in cirrhosis? * Does taking melatonin improve cognitive function and reported QoL? This is a pilot study, where participants will: * take one month of melatonin, followed by one month of thiamine, which is another supplement but is not suspected to impact sleep significantly. * Undergo cognitive testing and take surveys * Wear a commercial wearable sleep tracker * Have a formal sleep study and salivary melatonin collection at the end of taking each supplement at our sleep center Participants will be blinded, and neither they nor the researchers will know which supplement they are taking first and which they are taking second. They will also be randomized, with half starting with melatonin and the other half starting with thiamine.

Key facts

Study ID: NCT07046429
Run by: Weill Medical College of Cornell University
People needed: 18
Starts: 2025-08-05
Expected to finish: 2026-12-31
Last updated by the study team: 2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

NewYork-Presbyterian/Weill Cornell Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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