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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07046429
The ClinicalTrials.gov registry entry for NCT07046429 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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