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Impact of Short and Mistimed Sleep on Adolescents With ADHD: The Adolescent Attention and Circadian Timing Study (AACT)

13 août 2026 mis à jour par: Children's Hospital Medical Center, Cincinnati

Impact of Circadian Misalignment for Adolescents With ADHD: Observational and Mechanistic Data

Many adolescents go to bed late and wake up early for school. Science is only beginning to understand how sleep schedules can affect them. The investigators are interested in whether changing adolescents' sleep patterns affects their functioning, attention, and how they feel. The investigators are especially interested in the effects of changing both how much sleep adolescents get and when that sleep happens.

This study focuses on healthy 13-17-year-olds with ADHD. This study asks adolescents to systematically change their sleeping habits across a 3 week span. The first week, they follow a sleep schedule that fits reasonably well with the schedule they keep when they do not have to wake up early for any specific obligation (e.g., for school). The second week, they spend several nights in a "short sleep" condition, during which they get 6.5 hours in bed per night. The final week, they enter a sleep condition that allows for healthy sleep duration, but with a timing that is randomly assigned to either fit well with their preferred schedule or fit poorly with that schedule. During each week, they and their parents complete measures of their attention and other factors. At the end of each week, they attend an evening session to measure their internal body clock ("circadian phase"), as well as measures of attention and other thinking skills. The goal is to understand whether the benefits of healthy sleep duration depend on the timing of when that sleep occurs.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Stephen Becker, Ph.D.

Lieux d'étude

  • États-Unis
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45229
        • Recrutement
        • Cincinnati Children's Hospital Medical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Ages 13-17 years at time of informed consent/assent
  • Based on semi-structured clinical interview, participants must meet full DSM-5 criteria for ADHD inattentive or ADHD combined presentation.

Exclusion Criteria:

  • Non-traditional school setting (morning-afternoon Monday-Friday).
  • Exclusionary diagnoses. We will exclude adolescents with known intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, or neurologic conditions (e.g., epilepsy), per caregiver-report.
  • Exclusionary sleep disorders. We will exclude adolescents with symptoms of obstructive sleep apnea or periodic limb movement disorder based on published cutoffs on a validated questionnaire.

  • High caffeine intake. To promote adherence to directives not to consume caffeine the day of office visits without withdrawal effects, adolescents with daily intake of >1 coffee or "energy drink" or >2 caffeinated sodas per day based on caregiver- and adolescent-report will be excluded.

    • Unwillingness or inability to take part in study procedures (e.g., visits, prescribed sleep conditions).
    • Medication use or unwillingness to discontinue melatonin and/or stimulant medications during the 3-week study protocol.
  • Refusal to refrain from automobile driving during the sleep restriction condition.
  • "Intermediate" Chronotypes (neither morning larks nor night owls) based on habitual sleep timing on nights when adolescent has no morning obligations such as school or work.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Aligned Sleep Extension
One of two variants on the timing of period of when there is an opportunity to get healthy/recommended sleep duration. Aligned sleep extension allows 9.5 hours/night in bed in a manner that broadly fits with an adolescent's chronotype (e.g., early-to-bed and early-to-rise schedule for a morning lark).
Comportemental: Aligned sleep extension
Timing of extended sleep condition is randomly assigned to fit with participant's chronotype
Expérimental: Misaligned Sleep Extension
One of two variants on the timing of period of when there is an opportunity to get healthy/recommended sleep duration. Aligned sleep extension allows 9.5 hours/night in bed in a manner that is broadly a poor fit with an adolescent's chronotype (e.g., early-to-bed and early-to-rise schedule for a night owl).
Comportemental: Misaligned sleep extension
Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Caregiver- and Adolescent-Reported Symptoms of Inattention
Délai: Daily throughout each participant's involvement in the study, up to 3 weeks
Daily diary listing symptoms of inattention adapted from the IOWA Conners Questionnaire. Adolescents will self-report their own symptoms for the previous day. Parents/caregivers will report on their observations of the adolescents' symptoms for the previous day. Higher scores indicate greater inattention.
Daily throughout each participant's involvement in the study, up to 3 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety)
Délai: Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
Retrospective report of internalizing symptoms based on the Vanderbilt questionnaire across 5 days the previous week. Adolescents will self-report their own symptoms. Parents/caregivers will report on their observations of the adolescents' symptoms. Higher scores indicate greater internalizing symptoms.
Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
Caregiver- and Adolescent-Reported Emotional Dysregulation
Délai: Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
Retrospective report of symptoms of Emotion Dysregulation (e.g., emotional responses stronger than is called for by a situation) across 5 days the previous week. Previously validated by the investigators against established measures of long-term emotion regulation, this form focuses on a shorter (5-day) period. Adolescents will self-report their own symptoms. Parents/caregivers will report on their observations of the adolescents' symptoms. Higher scores indicate greater dysregulation.
Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
Caregiver- and Adolescent-Reported Impulsivity
Délai: Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
Retrospective report of internalizing symptoms based on the Vanderbilt questionnaire across 5 days the previous week. Adolescents will self-report their own symptoms. Parents/caregivers will report on their observations of the adolescents' symptoms. Higher scores indicate greater internalizing symptoms.
Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
Sleep Period Duration
Délai: Nightly throughout study participation (around 3 weeks)
Nightly sleep period, defined as the simple difference between sleep onset and offset, based on a wrist-mounted accelerometer (wristwatch).
Nightly throughout study participation (around 3 weeks)
Inattention
Délai: Twice daily during weeks 2 and 3 of study participation.
Adolescent-reported attention will me assessed via Ecological Momentary Assessment (EMA)
Twice daily during weeks 2 and 3 of study participation.
Inattention, as objectively measured via the NASA PVT+ application (aka Psychomotor Vigilance Test).
Délai: Four remote administrations: (1) the morning of a predetermined date during Week 2 of study participation; (2) the afternoon of that same Week 2 date; (3) the morning of a predetermined date during Week 3; (4) the afternoon of that same Week 3 date.
Remote-proctored administration via the NASA PVT+, loaded onto an iPhone. This is a computerized measure of sustained attention. Participants must attend to infrequent stimuli on screen as quickly as possible. Higher scores indicate slower or missed responses, and therefore greater inattention.
Four remote administrations: (1) the morning of a predetermined date during Week 2 of study participation; (2) the afternoon of that same Week 2 date; (3) the morning of a predetermined date during Week 3; (4) the afternoon of that same Week 3 date.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Children's Hospital Medical Center, Cincinnati

Collaborateurs

National Institute of Mental Health (NIMH)

Les enquêteurs

  • Chercheur principal: Dean Beebe, Ph.D., Children's Hospital Medical Center, Cincinnati
  • Chercheur principal: Stephen Becker, Ph.D., Children's Hospital Medical Center, Cincinnati

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juillet 2026

Achèvement primaire (Estimé)

1 août 2030

Achèvement de l'étude (Estimé)

1 août 2030

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

29 juin 2026

Première publication (Réel)

6 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 août 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R01MH139504 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Per sponsor policy, primary outcome data will be shared with the NIMH Data Archive (NDA).

Délai de partage IPD

Per NDA guidelines, data will be uploaded every 6 months throughout the study. Longevity of those data will be determined by the NIMH.

Critères d'accès au partage IPD

To access study data within NDA, users must submit at Data Request Checklist to NDA, sign the NIMH NDA Data Use Agreement, and submit proof of IRB approval. The Data Request Checklist will specify that data must be used for research purposes only, data will not be shared or sold, attempts will not be made to identify individual participants, etc. The NDA Data Access Committee will decide which requests to grant based on the information submitted. If given access, data access will be granted for one year but this is renewable. Should individuals or organizations request the dataset directly from the investigators, those requests will be directed to the NDA to retrieve the data.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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