Actively Recruiting
Affect of Melatonin on Sleep and Cognition in Cirrhosis
Led by Weill Medical College of Cornell University · Updated on 2025-08-28
18
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
A
American Association for the Study of Liver Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Affect of Melatonin on Sleep and Cognition in Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over age 18
- Diagnosed with cirrhosis with clinically significant portal hypertension or decompensation according to Baveno VII criteria
- Have covert hepatic encephalopathy (PHES ≤ -4) or previously diagnosed hepatic encephalopathy
- Experience disturbed sleep with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher
- Own a smartphone with Bluetooth and can download the Oura application (Apple iOS 14.0 or higher, or Android 8.0 or higher)
You will not qualify if you...
- Regular use of melatonin (3 times per week) and unable or unwilling to stop for the study
- Unable to provide informed consent
- Heavy current alcohol use (more than 7 drinks weekly for women and more than 14 drinks weekly for men)
- Body mass index over 40
- Known sleep disorders including obstructive sleep apnea
- Use of prescription neuromodulating sleep aids
- Pregnancy during study screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10021
Actively Recruiting
Research Team
A
Adam Buckholz, MD MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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