[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603586":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Baylor University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin (3mg)","EXPERIMENTAL","Participants will ingest an acute oral melatonin tablet (3mg) prior to stress reactivity assessment.",[13],"Dietary Supplement: Melatonin 3 MG Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will ingest a placebo pill of the same color and shape as the melatonin tablet prior to reactivity assessment.",[19],"Dietary Supplement: Placebo Oral Tablet",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Melatonin 3 MG Oral Tablet","Participants will ingest an acute 3mg oral melatonin tablet",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Oral Tablet","Participants will ingest a placebo tablet (sugar pill) of the same size, shape, and color of the active melatonin supplement",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jeremy A Bigalke, PhD","CONTACT","2547104399","jeremy_bigalke@baylor.edu",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Anna Murvich","254-710-4475","anna_muvich@baylor.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Baylor University Autonomic Function Laboratory","RECRUITING","Waco","Texas","76706","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-97.14667,31.54933,{"lat":54,"lon":53},[57,59],{"name":33,"role":34,"phone":58,"phoneExt":26,"email":36},"254-710-4399",{"name":33,"role":60,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100603586","influence-of-melatonin-on-cardiovascular-and-thermoregulatory-responses-to-stress-100603586",false,"NCT07138443","Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress","Influence of Melatonin on Cardiovascular and Skin Temperature Responses to Stress: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Must be between the ages of 18-70 years old.\n* All subjects will be required to abstain from exercise and caffeine for 12 h, and alcohol for 24 h prior to the experiment.\n* BMI must be \\\u003C30 kg\u002Fm2.\n* Menstruating women will initially be tested during their early follicular phase (2-5 days after initiating menstruation) or during low hormone phase (2-5 days after initiating menstruation) if on oral contraceptives to control for potential impact of sex steroids. Post-menopausal females (\\>5 years) will also be included. Females must have an intact uterus and at least one ovary. Use of hormonal replacement therapy will be allowed.\n\nExclusion Criteria:\n\n* Circadian rhythm sleep disorders\n* High obstructive sleep apnea diagnosis determined by STOP-BANG.\n* History of meeting Diagnostic and Statistical Manual of Mental health (DSM-V) criteria of major psychiatric disorder\n* Unstable or serious medical conditions (heart failure, diabetes, cardiovascular disease, etc.)\n* Current, or use within past month, of psychoactive (other than stable treatment with antidepressant), hypnotic, stimulant or analgesic medication (except occasional non-narcotic analgesics), beta blockers, or alpha blockers\n* Shift work or other types of self-imposed irregular sleep schedules\n* Habitual smoking (6 or more cigarettes per week)\n* Habitual alcohol consumption (more than 2 alcoholic drinks per day)\n* Pregnancy or breast feeding",true,"ALL","18 Years","70 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study aims to evaluate the influence of acute oral melatonin supplementation on cardiovascular and skin temperature responses to mental stress. The hypothesis is that acute melatonin will lead to reduced cardiovascular and skin temperature responsiveness to acute mental stress.",[82,83],"Stress","Mental Stress",[85,86,87,88,89],"Melatonin","Mental stress","Trier Social Stress Test","Cardiovascular","Skin temperature","2025-08-21",{"date":92,"type":93},"2025-08-22","ACTUAL",{"date":95,"type":76},"2025-08",{"date":97,"type":76},"2026-08",{"name":5,"class":6},1]