Affect of Melatonin on Sleep and Cognition in Cirrhosis
Recruiting
N/A
Interventional Study
Hepatic Encephalopathy
Covert Hepatic Encephalopathy
Cirrhosis
Sleep Disturbances and Insomnia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- Weill Medical College of Cornell University · Other
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About This Trial
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 co…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
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Contacts