Affect of Melatonin on Sleep and Cognition in Cirrhosis (NCT07046429) | Clinical Trial Compass
RecruitingNot Applicable
Affect of Melatonin on Sleep and Cognition in Cirrhosis
United States18 participantsStarted 2025-08-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in rapid eye movement (REM) sleep as a percentage of total sleep measured by polysomnography after melatonin vs thiamine
Timeframe: Approximately 4 weeks and 9 weeks, at polysomnography which marks the end of each treatment (melatonin or thiamine) assignment.
Trial details
NCT IDNCT07046429
SponsorWeill Medical College of Cornell University