RecruitingNot ApplicableNCT07046429

Affect of Melatonin on Sleep and Cognition in Cirrhosis

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

Sponsor

Weill Medical College of Cornell University

Enrollment

18 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Cirrhosis Hepatic Encephalopathy Covert Hepatic Encephalopathy Sleep Disturbances and Insomnia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether melatonin (a sleep hormone available as a supplement) can improve sleep quality and brain function in people with liver cirrhosis who have sleep problems and early-stage brain fog (a condition called hepatic encephalopathy, caused by the liver not clearing toxins properly). **You may be eligible if...** - You are over 18 with liver cirrhosis and significant portal hypertension or liver decompensation - You have poor sleep quality (PSQI score 5 or higher) - You have either mild cognitive impairment linked to liver disease (covert hepatic encephalopathy) or a prior episode of hepatic encephalopathy - You own a smartphone that can run the Oura app (Apple iOS 14+ or Android 8+) **You may NOT be eligible if...** - You regularly take melatonin (3 or more times per week) and cannot stop for the study - You have a BMI over 40 - You have a known sleep disorder like sleep apnea - You drink heavily (more than 7 drinks/week for women, 14 for men) - You are on other prescription sleep medications - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMelatonin tablet 3 mg once daily

Participants will be instructed to take 3 mg regular acting (not orally dissolving) melatonin 30 minutes before their anticipated bedtime, nightly for the 30 days preceding analysis of study endpoints.

DIETARY_SUPPLEMENTThiamine

Participants will be instructed to take 100 mg regular acting (not orally dissolving) thiamine 30 minutes before their anticipated bedtime, nightly for the 30 days preceding analysis of study endpoints.