ClinConnect ClinConnect Logo
Search / Trial NCT07046429

Affect of Melatonin on Sleep and Cognition in Cirrhosis

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jun 23, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Cirrhosis Hepatic Encephalopathy Covert Hepatic Encephalopathy Portal Hypertension Sleep Disturbances Insomnia Sleep Problems Wearable Technology

ClinConnect Summary

This clinical trial is looking at whether melatonin, a natural sleep aid, can help improve sleep, thinking skills, and overall quality of life in people with cirrhosis, a liver condition that can cause sleep problems and a brain-related complication called hepatic encephalopathy (HE). The study wants to see if melatonin can increase REM sleep, which is an important and restful part of sleep that is often reduced in people with cirrhosis, and if it can help with mental function and daily well-being.

Adults with cirrhosis who have signs of HE and trouble sleeping may be eligible to join. Participants need to have a smartphone to use a sleep-tracking app and should not regularly use melatonin or have other serious sleep disorders. During the study, participants will take melatonin for one month and then another supplement called thiamine for one month, but neither they nor the researchers will know the order (this is to fairly compare the effects). They will wear a sleep tracker, complete thinking tests and surveys, and have formal sleep studies at a sleep center. This study is not yet recruiting, but it aims to better understand how melatonin might help people with cirrhosis sleep and feel better.

Gender

ALL

Eligibility 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

About Weill Medical College Of Cornell University

Weill Medical College of Cornell University is a leading academic institution dedicated to advancing medical research and education. As a prominent sponsor of clinical trials, it focuses on innovative healthcare solutions and the development of new therapies across various medical disciplines. The institution is committed to fostering collaborative research efforts that enhance patient care and improve health outcomes. With a robust infrastructure and a team of experienced researchers and clinicians, Weill Cornell aims to translate scientific discoveries into practical applications, ensuring a strong emphasis on ethical standards and regulatory compliance throughout the clinical trial process.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Adam Buckholz, MD MS

Principal Investigator

NewYork-Presbyterian/Weill Cornell Medical College

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported