RECRUITING

Affect of Melatonin on Sleep and Cognition in Cirrhosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-08-05
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07046429

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cirrhosis with clinically significant portal hypertension or decompensation defined by Baveno VII criteria \[de Franchis R et al 2022\]
  2. * Adults over age 18
  3. * CHE (defined by PHES≤ -4) or previously diagnosed HE
  4. * Disturbed sleep, with Pittsburgh Sleep Quality Index (PSQI) ≥5
  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)
  1. * Use of melatonin regularly (3x per week) if unable/unwilling to discontinue for the study
  2. * Inability provide informed consent
  3. * Heavy current alcohol use (\>7 drinks weekly for women and 14 drinks weekly for men)'
  4. * Known prior sleep disorder including obstructive sleep apnea
  5. * Use of other prescription neuromodulating sleep aides
  6. * Self-reported pregnancy during study screening, as sleep physiology is different in this population

Contacts and Locations

Study Contact

Adam Buckholz, MD MS
CONTACT
646-962-5483
apb9012@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • cirrhosis
  • hepatic encephalopathy
  • covert hepatic encephalopathy
  • portal hypertension
  • sleep disturbances
  • insomnia
  • sleep problems
  • wearable technology

Additional Relevant MeSH Terms

  • Hepatic Encephalopathy
  • Covert Hepatic Encephalopathy
  • Cirrhosis
  • Sleep Disturbances and Insomnia