Affect of Melatonin on Sleep and Cognition in Cirrhosis (NCT07046429)
Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: NewYork-Presbyterian/Weill Cornell Medical Center — New York, New York
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- NewYork-Presbyterian/Weill Cornell Medical Center — New York, New York
📞 Contact the Study Coordinator
Phone: (646) 962-5483
Email: apb9012@med.cornell.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatic Encephalopathy
- Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis — Homewood, Alabama
- Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis — Dothan, Alabama
- Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy — Boston, Massachusetts
- Revealing Engagement Patterns Among Hepatic Encephalopathy Patients — San Francisco, California
- Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy — Newark, New Jersey
- Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE) — West Haven, Connecticut
Explore by condition: All Hepatic Encephalopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.