Duke University Medical Center
Durham, North Carolina, 27705, United States
NCT Number: NCT07805382
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.
Trial opening soon.
Get Notified11 year–15 year
Female
Observational
Durham, North Carolina, 27705, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 56 Days
The percentage of actual E2 data collected compared to anticipated E2 data collected
Time frame: 56 Days
The percentage of actual Garmin data collected compared to anticipated Garmin data collected
Time frame: 56 Days
The percentage of actual EMA data collected compared to anticipated EMA data collected
Contact information is provided by the study sponsor or research team.
Duke University
Other
Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD: A Pilot Study
Acronym: DREAMS
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.
Published trials that share one or more normalized conditions with this study.
NCT07661823
ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Richmond, Virginia, United States
View Trial DetailsNCT07756255
ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Calgary, Alberta, Canada
View Trial DetailsNCT07812948
ADHD, Attention Deficit Disorder with Hyperactivity
View Trial DetailsNCT07812714
ADHD, Attention Deficit Disorder with Hyperactivity
Paris, France
View Trial Details