ADHDDREAMSNCT07805382
Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD
An observational study of ADHD, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 15 years, women only
- Conditions the study is for
- ADHD
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- Women only
- No healthy volunteers
- Child
Study population: Female adolescents ages 11-15 with ADHD in the Duke University Health System
Who may be able to join
- 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);
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
Matthew Gibson, 9196812521, matthew.gibson646@duke.edu
About this study
Official title: Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Collecting Estradiol (E2)
The percentage of actual E2 data collected compared to anticipated E2 data collected
Measured: 56 Days
Feasibility of Collecting Garmin Data
The percentage of actual Garmin data collected compared to anticipated Garmin data collected
Measured: 56 Days
Feasibility of Collecting Ecological Momentary Assessments (EMA)
The percentage of actual EMA data collected compared to anticipated EMA data collected
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Lunsford-Avery, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805382
- Sponsor's protocol ID
- Pro00120484
- Acronym
- DREAMS
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD: A Pilot Study
- ClinicalTrials.gov ID
- NCT07805382
- Acronym / sponsor ID
- DREAMS / Pro00120484
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Female adolescents ages 11-15 with ADHD in the Duke University Health System
Key inclusion criteria (5 listed)
- 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);
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of Collecting Estradiol (E2)
Time frame: 56 Days
The percentage of actual E2 data collected compared to anticipated E2 data collected
Feasibility of Collecting Garmin Data
Time frame: 56 Days
The percentage of actual Garmin data collected compared to anticipated Garmin data collected
Feasibility of Collecting Ecological Momentary Assessments (EMA)
Time frame: 56 Days
The percentage of actual EMA data collected compared to anticipated EMA data collected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Lunsford-Avery, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Gibson (9196812521, matthew.gibson646@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Collecting Estradiol (E2) (time frame: 56 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.