- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07805382
Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD (DREAMS)
4. september 2026 opdateret af: Duke University
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 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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 R01 proposal 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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Matthew Gibson
- Telefonnummer: 9196812521
- E-mail: matthew.gibson646@duke.edu
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Duke University Medical Center
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Kontakt:
- Matthew Gibson
- Telefonnummer: 919-681-2521
- E-mail: matthew.gibson646@duke.edu
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Female adolescents ages 11-15 with ADHD in the Duke University Health System
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Adolescent Females with Attention Deficit Hyperactivity Disorder (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, 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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of Collecting Estradiol (E2)
Tidsramme: 56 Days
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The percentage of actual E2 data collected compared to anticipated E2 data collected
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56 Days
|
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Feasibility of Collecting Garmin Data
Tidsramme: 56 Days
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The percentage of actual Garmin data collected compared to anticipated Garmin data collected
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56 Days
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Feasibility of Collecting Ecological Momentary Assessments (EMA)
Tidsramme: 56 Days
|
The percentage of actual EMA data collected compared to anticipated EMA data collected
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56 Days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jessica Lusnford-Avery, Ph.D., Duke University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. august 2027
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
27. august 2026
Først indsendt, der opfyldte QC-kriterier
1. september 2026
Først opslået (Faktiske)
4. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00120484
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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