Melatonin to improve sleep and thinking in people with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized crossover pilot where participants take one month of melatonin and one month of thiamine in random order without knowing which they receive first. Participants will complete cognitive testing, quality-of-life surveys, wear a commercial sleep tracker, and undergo an overnight sleep study with salivary melatonin collection after each treatment period. The trial focuses on changes in sleep physiology—particularly REM sleep—as well as cognitive performance and patient-reported outcomes. The design allows within-subject comparison to limit variability in this small pilot cohort.

Why it matters

Who can join: the full rules

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

Where it's running

• NewYork-Presbyterian/Weill Cornell Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Adam Buckholz, MD MS — NewYork-Presbyterian/Weill Cornell Medical College
• Study coordinator: Adam Buckholz, MD MS
• Email: apb9012@med.cornell.edu
• Phone: 646-962-5483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.