Recruiting

Melatonin

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07046429

Conditions

Hepatic Encephalopathy

Covert Hepatic Encephalopathy

Cirrhosis

Sleep Disturbances and Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Melatonin tablet 3 mg once daily

Thiamine

Study Details

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.

Conditions

Hepatic Encephalopathy

Covert Hepatic Encephalopathy

Cirrhosis

Sleep Disturbances and Insomnia

Study ID

NCT07046429

Start date

Aug 5, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Melatonin then Thiamine

This group will take one month of melatonin, followed by a one week washout period, then one month of thiamine. They will have the primary outcomes assessed at each month, and will also undergo continuous sleep monitoring via a wearable tracker during all phases of the arm.

experimental: Thiamine then melatonin

This group will take one month of melatonin, followed by a one week washout period, then one month of thiamine. They will have the primary outcomes assessed at each month, and will also undergo continuous sleep monitoring via a wearable tracker during all phases of the arm.

Interventions

Melatonin tablet 3 mg once daily

Participants will be instructed to take 3 mg regular acting (not orally dissolving) melatonin 30 minutes before their anticipated bedtime, nightly for the 30 days preceding analysis of study endpoints.

Thiamine

Participants will be instructed to take 100 mg regular acting (not orally dissolving) thiamine 30 minutes before their anticipated bedtime, nightly for the 30 days preceding analysis of study endpoints.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Adam Buckholz, MD MS

646-962-5483apb9012@med.cornell.edu

Locations

NewYork-Presbyterian/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021

Contacts

Adam P Buckholz, MD MS

646-962-5483apb9012@med.cornell.edu

Cecilia Mero

cmm2002@med.cornell.edu

Principal Investigator:

Adam P Buckholz, MD MS

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • cirrhosis
  • hepatic encephalopathy
  • covert hepatic encephalopathy
  • portal hypertension
  • sleep disturbances
  • insomnia
  • sleep problems
  • wearable technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-07-29.