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Affect of Melatonin on Sleep and Cognition in Cirrhosis

NCT07046429 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-08-28

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046429 on ClinicalTrials.gov