[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654792":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":55,"collaborators":19,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":19,"briefSummary":72,"conditions":73,"keywords":19,"overallStatus":75,"whyStopped":19,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Feasibility of Collecting Estradiol (E2)","The percentage of actual E2 data collected compared to anticipated E2 data collected","56 Days",{"measure":14,"description":15,"timeFrame":12},"Feasibility of Collecting Garmin Data","The percentage of actual Garmin data collected compared to anticipated Garmin data collected",{"measure":17,"description":18,"timeFrame":12},"Feasibility of Collecting Ecological Momentary Assessments (EMA)","The percentage of actual EMA data collected compared to anticipated EMA data collected",null,{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":21,"timePerspective":22,"maskingInfo":19},"CASE_ONLY","PROSPECTIVE","The overall objective is to establish the feasibility of collecting estradiol (E2), Garmin-measured sleep, and ecological momentary assessments (EMA) of ADHD and related symptoms (mood, anxiety, executive functioning) among adolescent females with Attention Deficit Hyperactivity Disorder (ADHD) and explore the links between within-individual E2 variability and EMA-derived outcomes, across menstrual cycles in this population. We aim to establish sufficient pilot data to support a large-scale study focused on characterizing relationships between E2 across the menstrual cycle, sleep, ADHD symptoms, and related symptomatology in adolescent females with ADHD. Participants will complete an initial screening visit answering questionnaires related to puberty, ADHD, and sleep to establish eligibility. After completing a device training session, we will ask participants to provide daily urine E2 samples and EMA brief assessments of ADHD and related clinical features (i.e., mood, executive functioning, sleep) over 2 menstrual cycles (\\~56 days). Sleep will be assessed continuously over the study period via convenient wearable (Garmin watch). Feasibility of protocol will be assessed as days of successful E2 data collection, EMA completion, and Garmin wear. Feasibility benchmark=80% actual\u002Fanticipated data collection. Multilevel modeling will explore the relationship between within-person changes in E2, ADHD symptoms and related clinical outcomes, and whether sleep strengthens (moderates) these relationships.","Female adolescents ages 11-15 with ADHD in the Duke University Health System",[26],{"label":27,"type":19,"description":28,"interventionNames":19},"Adolescent Females with Attention Deficit Hyperactivity Disorder (ADHD)","Participants will complete an initial screening visit answering questionnaires related to puberty, ADHD, sleep, and psychiatric health to establish eligibility. After completing a device training session, participants will be asked to provide daily urine E2 samples and EMA brief assessments of ADHD and related clinical features (i.e., mood, executive functioning, sleep) over 2 menstrual cycles (\\~56 days).",[30],{"name":31,"affiliation":5,"role":32},"Jessica Lunsford-Avery, Ph.D.","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},"Matthew Gibson","CONTACT","9196812521","matthew.gibson646@duke.edu",[40],{"facility":41,"status":19,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Duke University Medical Center","Durham","North Carolina","27705","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-78.89862,35.99403,{"lat":51,"lon":50},[54],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},{"type":56,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100654792","dynamic-relationships-between-estrogen-fluctuations-sleep-and-psychiatric-complexity-among-adolescent-females-with-adhd-a-pilot-study-100654792",false,"NCT07805382","Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD","Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD: A Pilot Study","DREAMS","Inclusion Criteria:\n\n* Female;\n* Ages 11-15;\n* Within 2 years of first menstrual cycle (menarche);\n* Parent-reported ADHD diagnosis and T score ≥65 on Inattention and\u002For Hyperactivity\u002FImpulsivity via Conners\n* Access to internet and smartphone device with capacity to download the intervention App (iOS and Android);\n\nExclusion Criteria:\n\n* Reported psychotic or bipolar disorder, sleep apnea, or restless leg syndrome;\n* Current suicidality\u002Fself-harm;\n* Plans to initiate\u002Fchange psychotropic or sleep medications during participation","FEMALE","11 Years","15 Years",{"count":69,"type":70},30,"ESTIMATED","OBSERVATIONAL","The purpose of the study is to establish the feasibility of collecting estradiol (E2), Garmin-measured sleep, and ecological momentary assessments (EMA) of ADHD and related symptoms (mood, anxiety, executive functioning) across menstrual cycles among 20 peripubertal female adolescents aged 11-15 with ADHD, and to explore links between within-individual E2 variability, sleep, and EMA-derived outcomes.",[74],"ADHD","NOT_YET_RECRUITING","2026-09-17",{"date":78,"type":79},"2026-09-21","ACTUAL",{"date":81,"type":70},"2026-09",{"date":83,"type":70},"2027-08",{"name":5,"class":6},1]