Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD

NCT07805382 | Not Yet Recruiting

• 1 other identifier: Pro00120484
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• Feasibility of Collecting Estradiol (E2)

  The percentage of actual E2 data collected compared to anticipated E2 data collected

  56 Days

• Feasibility of Collecting Garmin Data

  The percentage of actual Garmin data collected compared to anticipated Garmin data collected

  56 Days

• Feasibility of Collecting Ecological Momentary Assessments (EMA)

  The percentage of actual EMA data collected compared to anticipated EMA data collected

  56 Days

Study Arms (1)

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).

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Female adolescents ages 11-15 with ADHD in the Duke University Health System

You 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 may not qualify 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jessica Lunsford-Avery, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Gibson

CONTACT

9196812521; matthew.gibson646@duke.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)