Clinical Trial

Affect of Melatonin on Sleep and Cognition in Cirrhosis

Study acronym: SNORE-HE
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-12 -> 2026-12-31 2026-07-30
minor Completion pushed: 2026-12 -> 2026-12-31 2026-07-30
Trial Details
NCT Number NCT07046429
Lead Sponsor Weill Medical College of Cornell University
Collaborators: American Association for the Study of Liver Diseases
Conditions Hepatic Encephalopathy, Covert Hepatic Encephalopathy, Cirrhosis, Sleep Disturbances and Insomnia
Enrollment 18 participants
Start Date 2025-08-05
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-29