Impact of Short and Mistimed Sleep on Adolescents With ADHD: The Adolescent Attention and Circadian Timing Study (AACT)
13 августа 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
50
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Dean Beebe, Ph.D
- Номер телефона: 513-636-3489
- Электронная почта: dean.beebe@cchmc.org
Учебное резервное копирование контактов
- Имя: Stephen Becker, Ph.D.
Места учебы
-
-
Ohio
-
Cincinnati, Ohio, Соединенные Штаты, 45229
- Рекрутинг
- Cincinnati Children's Hospital Medical Center
-
Контакт:
- Dean Beebe, Ph.D.
- Номер телефона: 513-636-3489
- Электронная почта: dean.beebe@cchmc.org
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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).
|
Timing of extended sleep condition is randomly assigned to fit with participant's chronotype
|
|
Экспериментальный: 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).
|
Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Caregiver- and Adolescent-Reported Symptoms of Inattention
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).
Временное ограничение: 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.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Dean Beebe, Ph.D., Children's Hospital Medical Center, Cincinnati
- Главный следователь: Stephen Becker, Ph.D., Children's Hospital Medical Center, Cincinnati
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
10 июля 2026 г.
Первичное завершение (Оцененный)
1 августа 2030 г.
Завершение исследования (Оцененный)
1 августа 2030 г.
Даты регистрации исследования
Первый отправленный
10 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
29 июня 2026 г.
Первый опубликованный (Действительный)
6 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 августа 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- R01MH139504 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Per sponsor policy, primary outcome data will be shared with the NIMH Data Archive (NDA).
Сроки обмена IPD
Per NDA guidelines, data will be uploaded every 6 months throughout the study.
Longevity of those data will be determined by the NIMH.
Критерии совместного доступа к 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .