What this study is
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.
Study details
- Official title
- Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD: A Pilot Study
- Sponsor
- Duke University
- Conditions
- ADHD
- Enrolling
- 30 people
- Starts
- 2026-09
- Est. completion
- 2027-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 11 Years – 15 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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);
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDuke University Medical Center
Durham, North Carolina, United States
- Matthew Gibson · Contact9196812521matthew.gibson646@duke.edu
Study team
Sponsor
Duke University
Study ID Pro00120484
Principal investigator
Jessica Lunsford-Avery, Ph.D.
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.