Affect of Melatonin on Sleep and Cognition in Cirrhosis

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07046429
Status
Recruiting
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Conditions

  • Cirrhosis
  • Covert Hepatic Encephalopathy
  • Hepatic Encephalopathy
  • Sleep Disturbances and Insomnia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Melatonin tablet 3 mg once daily — DIETARY_SUPPLEMENT
    Participants will be instructed to take 3 mg regular acting (not orally dissolving) melatonin 30 minutes before their anticipated bedtime, nightly for the 30 days preceding analysis of study endpoints.
  • Thiamine — DIETARY_SUPPLEMENT
    Participants will be instructed to take 100 mg regular acting (not orally dissolving) thiamine 30 minutes before their anticipated bedtime, nightly for the 30 days preceding analysis of study endpoints.

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Melatonin then Thiamine
    This group will take one month of melatonin, followed by a one week washout period, then one month of thiamine. They will have the primary outcomes assessed at each month, and will also undergo continuous sleep monitoring via a wearable tracker during all phases of the arm.
  • Experimental: Thiamine then melatonin
    This group will take one month of melatonin, followed by a one week washout period, then one month of thiamine. They will have the primary outcomes assessed at each month, and will also undergo continuous sleep monitoring via a wearable tracker during all phases of the arm.

Primary Outcome Measure

Mean change in rapid eye movement (REM) sleep as a percentage of total sleep measured by polysomnography after melatonin vs thiamine [ Time Frame: Approximately 4 weeks and 9 weeks, at polysomnography which marks the end of each treatment (melatonin or thiamine) assignment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NewYork-Presbyterian/Weill Cornell Medical CenterNew YorkNew York10021
Adam P Buckholz, MD MS
[email protected]
646-962-5483
Cecilia Mero
[email protected]
Adam P Buckholz, MD MS (PRINCIPAL_INVESTIGATOR)
Robert S. Brown, Jr., MD MPH (SUB_INVESTIGATOR)

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By research site
NewYork-Presbyterian/Weill Cornell Medical Center· New York, NY

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