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Melatonin for Sleep and Cognition in Cirrhosis

This study is looking at how melatonin affects sleep, thinking abilities (cognitive function), and quality of life in people with cirrhosis (scarring of the liver) and hepatic encephalopathy (HE), a brain disorder caused by liver disease. You might be able to join if you are an adult with cirrhosis, HE, and sleep problems. The study wants to see if taking 3 mg of melatonin daily can improve a specific type of sleep called REM sleep, and also improve your thinking and how you feel overall. You would take melatonin for one month, followed by thiamine (another supplement not expected to affect sleep) for one month. This is a small pilot study planning to enroll 18 participants.

Study design
This is an interventional pilot study with 18 participants. It compares the effects of melatonin to thiamine.
What's involved
You would take either melatonin or thiamine daily for 30 days for each treatment period. Sleep will be measured by polysomnography at approximately 4 and 9 weeks.
Compensation
Not stated in the trial record.
Follow-up
Sleep is measured at approximately 4 weeks and 9 weeks, marking the end of each treatment assignment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07046429

Affect of Melatonin on Sleep and Cognition in Cirrhosis

Recruiting
NAAges 18+InterventionalTreatment
Weill Medical College of Cornell University
~18 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Melatonin tablet 3 mg once dailyThiamine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in rapid eye movement (REM) sleep as a percentage of total sleep measured by polysomnography after melatonin vs thiamine
Measured over Approximately 4 weeks and 9 weeks, at polysomnography which marks the end of each treatment (melatonin or thiamine) assignment.

Conditions

Hepatic Encephalopathy
Covert Hepatic Encephalopathy
Cirrhosis
Sleep Disturbances and Insomnia

Explore related trials

CirrhosisHepatic Encephalopathy

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Adam Buckholz, MD MS
[email protected]
646-962-5483
Email the study team

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Eligibility criteria

Inclusion

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

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)'
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

What this trial measures

  • Mean change in rapid eye movement (REM) sleep as a percentage of total sleep measured by polysomnography after melatonin vs thiamineApproximately 4 weeks and 9 weeks, at polysomnography which marks the end of each treatment (melatonin or thiamine) assignment.

    Prior research by the investigators and other groups have suggested that patients with hepatic encephalopathy have reduced REM sleep, which is a critical sleep phase that contributes to daytime attention, cognition, and mental/emotional wellbeing. Melatonin has been noted in small studies to increase the amount of nightly REM sleep but is understudied in cirrhosis. The primary outcome of this study will be to determine whether relative to thiamine, use of melatonin increases the absolute nightly amount of REM sleep and the percentage of nightly sleep spent in REM. This outcome will be measured by polysomnography, the gold standard for sleep stage determination..