[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596512":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":63,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":24,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin then Thiamine","EXPERIMENTAL","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.",[13,14],"Dietary Supplement: Melatonin tablet 3 mg once daily","Dietary Supplement: Thiamine",{"label":16,"type":10,"description":11,"interventionNames":17},"Thiamine then melatonin",[13,14],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","Melatonin tablet 3 mg once daily","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.",[9,16],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Thiamine","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.",[9,16],[30],{"name":31,"affiliation":32,"role":33},"Adam Buckholz, MD MS","NewYork-Presbyterian\u002FWeill Cornell Medical College","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","646-962-5483","apb9012@med.cornell.edu",[40],{"facility":41,"status":42,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"NewYork-Presbyterian\u002FWeill Cornell Medical Center","RECRUITING","New York","10021","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-74.00597,40.71427,{"lat":51,"lon":50},[54,56,59,60],{"name":55,"role":36,"phone":37,"phoneExt":24,"email":38},"Adam P Buckholz, MD MS",{"name":57,"role":36,"phone":24,"phoneExt":24,"email":58},"Cecilia Mero","cmm2002@med.cornell.edu",{"name":55,"role":33,"phone":24,"phoneExt":24,"email":24},{"name":61,"role":62,"phone":24,"phoneExt":24,"email":24},"Robert S. Brown, Jr., MD MPH","SUB_INVESTIGATOR",{"type":64,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[66],{"name":67,"class":6},"American Association for the Study of Liver Diseases","100596512","affect-of-melatonin-on-sleep-and-cognition-in-cirrhosis-100596512",false,"NCT07046429","Affect of Melatonin on Sleep and Cognition in Cirrhosis","Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial","SNORE-HE","Inclusion Criteria:\n\n* Cirrhosis with clinically significant portal hypertension or decompensation defined by Baveno VII criteria \\[de Franchis R et al 2022\\]\n* Adults over age 18\n* CHE (defined by PHES≤ -4) or previously diagnosed HE\n* Disturbed sleep, with Pittsburgh Sleep Quality Index (PSQI) ≥5\n* 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)\n\nExclusion Criteria:\n\n* Use of melatonin regularly (3x per week) if unable\u002Funwilling to discontinue for the study\n* Inability provide informed consent\n* Heavy current alcohol use (\\>7 drinks weekly for women and 14 drinks weekly for men)'\n\n  \\-- Body mass index \\>40\n* Known prior sleep disorder including obstructive sleep apnea\n* Use of other prescription neuromodulating sleep aides\n* Self-reported pregnancy during study screening, as sleep physiology is different in this population","ALL","18 Years",{"count":79,"type":80},18,"ESTIMATED","INTERVENTIONAL",[83],"NA","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:\n\n* Does taking melatonin increase REM sleep, an important part of healthy sleep that is reduced in cirrhosis?\n* Does taking melatonin improve cognitive function and reported QoL?\n\nThis is a pilot study, where participants will:\n\n* take one month of melatonin, followed by one month of thiamine, which is another supplement but is not suspected to impact sleep significantly.\n* Undergo cognitive testing and take surveys\n* Wear a commercial wearable sleep tracker\n* 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.",[86,87,88,89],"Hepatic Encephalopathy","Covert Hepatic Encephalopathy","Cirrhosis","Sleep Disturbances and Insomnia",[91,92,93,94,95,96,97,98],"cirrhosis","hepatic encephalopathy","covert hepatic encephalopathy","portal hypertension","sleep disturbances","insomnia","sleep problems","wearable technology","2025-08-26",{"date":101,"type":102},"2025-08-28","ACTUAL",{"date":104,"type":102},"2025-08-05",{"date":106,"type":80},"2026-12",{"name":5,"class":6},1]