[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06768749":3,"trial-entities:NCT06768749":141,"trial-summary:NCT06768749":147},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":48,"secondary_outcomes":80,"sex":98,"minimum_age":99,"maximum_age":100,"healthy_volunteers":15,"eligibility_criteria":101,"std_ages":111,"locations":113,"central_contacts":130,"overall_officials":137,"references":139,"see_also_links":140},"NCT06768749","2024-032","The Impact of Melatonin Lotion on Sleep and Mental Health","The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects","RECRUITING","2028-04-01","2026-04","2026-05-01","2025-02-28","University of Redlands","OTHER",false,"The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.","All participants will receive a melatonin lotion and a placebo lotion in a randomized crossover design. Participants will receive equipment and supplies on a Monday and will begin the assigned treatment that night, by self-applying premeasured lotion 1 hour before bedtime. During the two treatment weeks, participants will wear ActiGraph GT3X-BT accelerometers (ActiGraph, Pensacola, FL) at all times except when bathing or submerged in water. They will wear Polar H10 heart rate monitor chest straps (Polar Electro, Kempele, Finland) from one hour prior to bedtime until after a 5 min sitting period after waking. Three times daily they will be asked 1-item mood\u002Fanxiety questions (\"How \\_\\_\\_ do you feel right now?\") through REDCap software. Participants will check any experienced side effects off a checklist once daily. Participants will collect a passive drool sample daily at bedtime and store in their home freezer until returning the samples to the laboratory. Treatment will occur for seven nights, with a return of equipment and saliva samples as well as confirmation of actigraphy and HRV readings the following Monday. After a seven day washout period to reduce any carryover effects, equipment and supplies will be supplied the next Monday and the participant will begin the other assigned treatment (active or placebo) that night in a crossover design. At three timepoints (pre-treatment, at the end of the melatonin treatment week, and at the end of the placebo week), participants will answer the following surveys online via REDCap: PROMIS short forms for anxiety, depression, sleep quality, and sleep-related impairment.",[19,20],"Sleep Problems","Depressive Disorder and Anxiety Disorders",[22,23,24,25,26,27,28,29],"melatonin","sleep","heart rate variability","actigraphy","amylase","mood","anxiety","depression","INTERVENTIONAL","BASIC_SCIENCE",[33],"NA",{"count":35,"type":36},60,"ESTIMATED",[38,44],{"type":14,"name":39,"description":40,"armGroupLabels":41},"Melatonin lotion","3 g lotion applied one hour before bedtime",[42,43],"Melatonin lotion first","Placebo lotion first",{"type":14,"name":45,"description":46,"armGroupLabels":47},"Placebo lotion","3 g of placebo lotion (scent-matched control) applied one hour before bedtime",[42,43],[49,53,56,59,63,66,69,73,76],{"measure":50,"description":51,"timeFrame":52},"Sleep disturbance","PROMIS SF v1.0 - Sleep Disturb 8b","Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)",{"measure":54,"description":55,"timeFrame":52},"Anxiety","PROMIS SF v1.0 - Anxiety 8a",{"measure":57,"description":58,"timeFrame":52},"Depression","PROMIS SF v1.0 - Depression 8b",{"measure":60,"description":61,"timeFrame":62},"Total sleep time","Measured via actigraphy","Two weeks of data separated by a one week period",{"measure":64,"description":65,"timeFrame":62},"Sleep efficiency","Measured by actigraphy",{"measure":67,"description":68,"timeFrame":62},"Normalized high frequency power of heart rate variability","5 min period during sleep latency, overnight recording while sleeping, and 5 min period sitting upright each morning",{"measure":70,"description":71,"timeFrame":72},"Anxiety by momentary ecological assessment","One item question: \"How anxious do you feel right now?\"","Three times per day for two weeks of data separated by a one week period",{"measure":74,"description":75,"timeFrame":72},"Mood by momentary ecological assessment","Single-item questions (\"How \\_\\_\\_ do you feel right now?)",{"measure":77,"description":78,"timeFrame":79},"Salivary alpha-amylase","As an indicator of sympathetic nervous system activity","Daily at bedtime for two weeks of data separated by a one week period",[81,84,87,90,94],{"measure":82,"description":83,"timeFrame":52},"Sleep-related impairment","PROMIS SF v1.0 - Sleep-Related Impairment 8a",{"measure":85,"description":86,"timeFrame":62},"Other sleep variables","A MANOVA will be conducted with the primary sleep outcomes as well as sleep onset latency (both self-reported and as measured by actigraphy) and subjective sleep quality",{"measure":88,"description":89,"timeFrame":79},"Salivary melatonin","For confirmation of protocol compliance",{"measure":91,"description":92,"timeFrame":93},"Other HRV variables","A MANOVA will be conducted with autonomic nervous system indicators including normalized high frequency HRV and salivary alpha amylase as primary outcomes, but also including LF\u002FHF ratio, RMSSD, and pNN50","5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime",{"measure":95,"description":96,"timeFrame":97},"Side effects","Frequency of headache, drowsiness, skin irritation, vivid dreams, nightmares, dizziness, and other","Daily for two weeks of data separated by a one week period","ALL","18 Years","21 Years",{"inclusion":102,"exclusion":105,"raw_text":110},[103,104],"a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and","a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)",[106,107,108,109],"currently using antidepressant, anti-anxiety, or sleep medication including melatonin","are pregnant","have allergies\u002Fsensitivities to scented lotion","are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.","Inclusion Criteria:\n\n* a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and\n* a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)\n\nExclusion Criteria:\n\n* currently using antidepressant, anti-anxiety, or sleep medication including melatonin\n* are pregnant\n* have allergies\u002Fsensitivities to scented lotion\n* are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.",[112],"ADULT",[114],{"facility":13,"status":8,"city":115,"state":116,"zip":117,"country":118,"contacts":119,"geoPoint":127},"Redlands","California","92374","United States",[120,125],{"name":121,"role":122,"phone":123,"email":124},"Lisa Olson, Ph.D.","CONTACT","909-748-8524","lisa_olson@redlands.edu",{"name":121,"role":126},"PRINCIPAL_INVESTIGATOR",{"lat":128,"lon":129},34.05557,-117.18254,[131,133],{"name":132,"role":122,"phone":123,"email":124},"Lisa E Olson, Ph.D.",{"name":134,"role":122,"phone":135,"email":136},"Steven Moore, Ph.D.","(909) 748-8687","steven_moore@redlands.edu",[138],{"name":132,"affiliation":13,"role":126},[],[],{"nct_id":4,"conditions":142,"biomarkers":146},[143,144,145],"Anxiety Disorder","Depressive disorder","Dyssomnia",[],{"nct_id":4,"found":148,"summary":149,"prompt_version":159},true,{"design":150,"status":151,"heading":152,"summary":153,"follow_up":154,"word_count":155,"commitments":156,"compensation":157,"drugs_mentioned":158},"This is an interventional study with 60 planned participants. All participants will receive both melatonin lotion and a placebo lotion in a randomized crossover design, meaning the order in which you receive them is random.","completed","Melatonin Lotion for Sleep and Mental Health in Young Adults","This study is testing if a melatonin lotion can help young adults (ages 18-21) who have sleep problems, anxiety, or depression. Melatonin is a natural hormone that helps regulate sleep. You would apply 3 grams of melatonin lotion or a placebo lotion (a lotion without medicine, but with the same scent) to your skin one hour before bedtime. Researchers will measure your sleep disturbance, anxiety, and depression levels to see if the melatonin lotion helps. To join, you need to have specific scores on surveys related to sleep disturbance, anxiety, or depression. You cannot be pregnant or currently using certain medications for sleep, anxiety, or depression, including melatonin. The study aims to enroll 60 participants, but its current status is unclear.","Your sleep, anxiety, and depression will be measured at the beginning, after the placebo week, and after the active treatment week (3 weeks total).",121,"You will self-apply lotion nightly for two separate weeks, wear a wrist device (actigraph) and a chest strap (heart rate monitor), answer daily mood questions, and collect nightly saliva samples. There will be a seven-day break (washout period) between the two treatment weeks.","Not stated in the trial record.",[39,45],"v2"]