Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD: A Pilot Study

Part of paid clinical trials in Durham, North Carolina.

Sponsor: Duke University
Study ID: NCT07805382
Status: Not Yet Recruiting

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Conditions

ADHD

Eligibility Criteria

Sex: FEMALE
Age: 11 Years - 15 Years
Healthy Volunteers: Not accepted

Study Details

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.

Key Dates

First listed: Sep 4, 2026
Start date: Sep 30, 2026
Status verified: Sep 2026
Primary completion: Aug 31, 2027
Completion: Aug 31, 2027

Study Design

Enrollment: 30 participants (estimated)

Arms

Arm: Adolescent Females with Attention Deficit Hyperactivity Disorder (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, 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).