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NCT07046429 · ClinicalTrials.gov registry record · NA
Affect of Melatonin on Sleep and Cognition in Cirrhosis
A NA study of Cirrhosis and Hepatic Encephalopathy, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT07046429: Recruiting NA study of Cirrhosis and Hepatic Encephalopathy, sponsored by Weill Medical College of Cornell University.
NCT07046429 is a NA study of Cirrhosis and Hepatic Encephalopathy that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 18 participants, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07046429, a NA study of Cirrhosis and Hepatic Encephalopathy, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Prior research by the investigators and other groups have suggested that patients with hepatic encephalopathy have reduced REM sleep, which is a critical sleep phase that contributes to daytime attention, cognition, and mental/emotional wellbeing. Melatonin has been noted in small studies to increase the amount of nightly REM sleep but is understudied in cirrhosis. The primary outcome of this study will be to determine whether relative to thiamine, use of melatonin increases the absolute nightly
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Thiamine
- DIETARY_SUPPLEMENT Melatonin tablet 3 mg once daily
Study Locations (1)
New York
- NewYork-Presbyterian/Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-08-05 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT07046429 shows while recruiting
NCT07046429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Thiamine is the first listed.
NCT07046429 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07046429 about?
NCT07046429 is a clinical study titled "Affect of Melatonin on Sleep and Cognition in Cirrhosis". 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,...
What is the current status of trial NCT07046429?
This trial is currently recruiting. It is a NA study. The enrollment target is 18 participants. The study started on 2025-08-05. Estimated completion is 2026-12.
What conditions does trial NCT07046429 study?
This clinical trial studies the following conditions: Cirrhosis, Hepatic Encephalopathy, Covert Hepatic Encephalopathy, Sleep Disturbances and Insomnia.
What interventions are being tested in trial NCT07046429?
The interventions under investigation include: Thiamine (DIETARY_SUPPLEMENT), Melatonin tablet 3 mg once daily (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07046429?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07046429 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07046429's enrollment target sits among peer trials
18 47th of 53 higher than 7 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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