Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial
Sponsor: Weill Medical College of Cornell University
Trial Details
| Condition | Hepatic Encephalopathy, Covert Hepatic Encephalopathy, Cirrhosis, Sleep Disturbances and Insomnia |
| Intervention | Melatonin tablet 3 mg once daily; Thiamine |
| Phase | NA |
| Status | Recruiting |
| Participants | 18 |
| Est. Completion | 31 Dec 2026 |
| Last Updated | 29 July 2026 |
Primary Outcome
Mean change in rapid eye movement (REM) sleep as a percentage of total sleep measured by polysomnography after melatonin vs thiamine
Eligibility Criteria
Inclusion 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
Trial Sites
Countries
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