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Affect of Melatonin on Sleep and Cognition in Cirrhosis

Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Melatonin tablet 3 mg once daily (dietary supplement)
• Thiamine (dietary supplement)

Sponsor: Weill Medical College of Cornell University · Participants: 18 · Started: Aug 5, 2025

Contact the study team

• Adam Buckholz, MD MS · Phone: 646-962-5483

Official record on ClinicalTrials.gov — NCT07046429

Locations in the U.S.

Conditions

• Parasomnias
• Insomnia
• Portal Hypertension

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.