NCT07046429 Affect of Melatonin on Sleep and Cognition in Cirrhosis
| NCT ID | NCT07046429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Hepatic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2025-08-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Adam Buckholz, MD MS
PRINCIPAL INVESTIGATOR
NewYork-Presbyterian/Weill Cornell Medical College
Frequently Asked Questions
Who can join the NCT07046429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07046429 currently recruiting?
Yes, NCT07046429 is actively recruiting participants. Contact the research team at apb9012@med.cornell.edu for enrollment information.
Where is the NCT07046429 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07046429 clinical trial?
NCT07046429 is sponsored by Weill Medical College of Cornell University. The principal investigator is Adam Buckholz, MD MS at NewYork-Presbyterian/Weill Cornell Medical College. The trial plans to enroll 18 participants.