NCT07046429Recruiting
Affect of Melatonin on Sleep and Cognition in Cirrhosis
Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 23 Jun 2025
- Start date
- 5 Aug 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- High blood pressure
- NCT number
- NCT07046429
What you commit to
- Study type: Interventional
- Planned participants: 18
- From 5 Aug 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known prior sleep disorder including obstructive sleep apnea
Other
- 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
- Use of other prescription neuromodulating sleep aides
- Self-reported pregnancy during study screening, as sleep physiology is different in this population
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NewYork-Presbyterian Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.