Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Melatonin may ease sleep and brain fog in liver disease — a trial puts it to the test

NCT ID NCT07046429

Symptom relief Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This pilot study tests whether taking melatonin at night can increase REM sleep and improve cognitive function in people with cirrhosis who have a complication called hepatic encephalopathy (HE). Participants take melatonin for one month and a control supplement (thiamine) for another month, while wearing a sleep tracker and undergoing cognitive tests and sleep studies. The goal is to see if a simple, widely available supplement can help with the sleep disturbances and mental fog that often accompany advanced liver disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
melatonin 3 mg tablet taken nightly for 30 days, compared with thiamine 100 mg tablet as a control
What this could lead to
If it works, melatonin could offer a simple, low-cost way to improve sleep and brain function in people with cirrhosis and hepatic encephalopathy.
What could go wrong
This is a very small pilot study with only 18 participants, so results may not apply broadly. Melatonin can cause drowsiness, dizziness, or headaches, and its long-term effects in liver disease are not well studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cirrhosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatic encephalopathy insomnia Parasomnias portal hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis Covert hepatic encephalopathy Hepatic encephalopathy Sleep disturbances and insomnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NewYork-Presbyterian/Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.