RECRUITING

Affect of Melatonin on Sleep and Cognition in Cirrhosis

Description

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.

Study Overview

Study Details

Study overview

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.

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

Affect of Melatonin on Sleep and Cognition in Cirrhosis

Condition
Hepatic Encephalopathy
Intervention / Treatment

-

Contacts and Locations

New York

NewYork-Presbyterian/Weill Cornell Medical Center, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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)'
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Adam Buckholz, MD MS, PRINCIPAL_INVESTIGATOR, NewYork-Presbyterian/Weill Cornell Medical College

Study Record Dates

2026-12