Melatonin to improve sleep and thinking in people with cirrhosis
Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial
This study will try one month of daily melatonin (compared with one month of thiamine) to see if it improves sleep and thinking in adults with cirrhosis and hepatic encephalopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07046429 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized crossover pilot where participants take one month of melatonin and one month of thiamine in random order without knowing which they receive first. Participants will complete cognitive testing, quality-of-life surveys, wear a commercial sleep tracker, and undergo an overnight sleep study with salivary melatonin collection after each treatment period. The trial focuses on changes in sleep physiology—particularly REM sleep—as well as cognitive performance and patient-reported outcomes. The design allows within-subject comparison to limit variability in this small pilot cohort.
Who should consider this trial
Good fit: Adults with cirrhosis and clinically significant portal hypertension or decompensation who have covert or prior hepatic encephalopathy (PHES ≤ -4), disturbed sleep (PSQI ≥ 5), and a compatible smartphone are ideal candidates.
Not a fit: People who are regular melatonin users who won’t stop, have known sleep disorders like obstructive sleep apnea, BMI > 40, heavy current alcohol use, or are pregnant are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, melatonin could increase REM sleep and lead to measurable improvements in cognition and quality of life for patients with cirrhosis and hepatic encephalopathy.
How similar studies have performed: Melatonin has improved sleep in other populations, but its effects on REM sleep and cognition specifically in cirrhosis are largely untested, so this is a pilot exploration.
Eligibility criteria
Show full inclusion / exclusion 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 * Possession of a "smart phone" with Bluetooth capability and ability to download the Oura application (Apple iOS version 14.0 or greater or Android version 8.0 or higher) Exclusion Criteria: * 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
Where this trial is running
New York, New York
- NewYork-Presbyterian/Weill Cornell Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Adam Buckholz, MD MS — NewYork-Presbyterian/Weill Cornell Medical College
- Study coordinator: Adam Buckholz, MD MS
- Email: apb9012@med.cornell.edu
- Phone: 646-962-5483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.