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NCT Number: NCT07805382

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

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.

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Key information

Age range

11 year–15 year

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location contact

Matthew Gibson

CONTACT

[email protected]

9196812521

About this study

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/anticipated 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility of Collecting Estradiol (E2)

    Time frame: 56 Days

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

  2. Feasibility of Collecting Garmin Data

    Time frame: 56 Days

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

  3. Feasibility of Collecting Ecological Momentary Assessments (EMA)

    Time frame: 56 Days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Gibson

CONTACT

[email protected]

9196812521

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: DREAMS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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