[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493193":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":61,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin group","EXPERIMENTAL","These subjects will receive melatonin",[13],"Dietary Supplement: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","These subjects will receive placebo",[19],"Other: Placebo",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Melatonin",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Placebo control",[15],[31],{"name":32,"affiliation":5,"role":33},"Lauren Dunn, MD PHD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Keita Ikeda, PH.D.","CONTACT","9195931174","ki2d@uvahealth.org",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Emily Chuang, MA","7575348912","QGZ2TK@uvahealth.org",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Charlottesville","Virginia","22908-0710","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-78.47668,38.02931,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":38,"phoneExt":25,"email":39},"Keita Ikeda, PhD",{"type":33,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lauren Dunn, MD","Assistant Professor","100493193","early-phase-1-effect-of-melatonin-on-sleep-patterns-of-resident-trainees-during-night-float-shift-100493193",false,"NCT05701969","Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift","Inclusion Criteria:\n\n* Post-Graduate Year 1-5\n* Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the Unversity of Virginia\n\nExclusion Criteria:\n\n* Current use of sleep aids\n* Diagnosed sleep disorder\n* History of a pacemaker or other medical device.\n* pregnant or breast-feeding females\n* Bleeding disorders\n* Depression\n* High blood pressure\n* Seizure disorders\n* History of transplant on immunosuppression therapy.",true,"ALL","18 Years",{"count":74,"type":75},50,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","Anesthesiology residency requires extended and overnight shifts, which may negatively impact the quantity and quality of sleep.\n\nPrevious studies have investigated the effect of night float shift work on anesthesiology resident sleep and performance and demonstrated that total sleep quantity and time spent in deep and rapid eye movement (REM) sleep were significantly reduced during night float and did not return to baseline after 3 nights of recovery.\n\nMelatonin is a hormone produced by the pineal gland, which regulates the circadian rhythm that governs sleep. Exogenous melatonin may be used as a sleep aid and is available over the counter in the United States. Melatonin is effective in realigning the circadian rhythm disorder caused by night shift work and increasing sleep duration; however, melatonin's effect on improving sleep in resident trainees has not been investigated. The investigators propose a prospective double-blinded randomized control trial to investigate the effect of melatonin on sleep quantity and quality in resident physicians assigned to a night float system.",[81],"Sleep Disorders, Circadian Rhythm","2026-04-27",{"date":84,"type":85},"2026-05-04","ACTUAL",{"date":87,"type":85},"2022-05-30",{"date":89,"type":75},"2028-06-30",{"name":5,"class":6},1]