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NCT07805382
Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD
Conditions: ADHD
Sex: Female
Ages: 11 Years – 15 Years
Healthy volunteers: No
Enrollment: 30
Sponsor: Duke University
Location: Duke University Medical Center Durham North Carolina
Summary
The purpose of the study is to establish the feasibility of collecting 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.
Eligibility Criteria
Inclusion Criteria:
* Female;
* Ages 11-15;
* Within 2 years of first menstrual cycle (menarche);
* Parent-reported ADHD diagnosis and T score ≥65 on Inattention and/or Hyperactivity/Impulsivity via Conners
* Access to internet and smartphone device with capacity to download the intervention App (iOS and Android);
Exclusion Criteria:
* Reported psychotic or bipolar disorder, sleep apnea, or restless leg syndrome;
* Current suicidality/self-harm;
* Plans to initiate/change psychotropic or sleep medications during participation
Source: ClinicalTrials.gov (NCT07805382). StuddyBuddy aggregates publicly available trial information.