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New treatment option for Hepatic Encephalopathy
Official title Affect of Melatonin on Sleep and Cognition in Cirrhosis
ClinicalTrials.gov ID: NCT07046429
What this study is testing
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
- Known prior sleep disorder including obstructive sleep apnea
- Use of other prescription neuromodulating sleep aides
- Self-reported pregnancy during study screening, as sleep physiology is different in this population
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Higher-pay potential.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.