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

2026年8月13日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Stephen Becker, Ph.D.

学习地点

  • 美国
    • Ohio
      • Cincinnati、Ohio、美国、45229
        • 招聘中
        • Cincinnati Children's Hospital Medical Center
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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).
行为的：Aligned sleep extension
Timing of extended sleep condition is randomly assigned to fit with participant's chronotype
实验性的：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).
行为的：Misaligned sleep extension
Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Caregiver- and Adolescent-Reported Symptoms of Inattention
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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).
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Children's Hospital Medical Center, Cincinnati

合作者

National Institute of Mental Health (NIMH)

调查人员

  • 首席研究员：Dean Beebe, Ph.D.、Children's Hospital Medical Center, Cincinnati
  • 首席研究员：Stephen Becker, Ph.D.、Children's Hospital Medical Center, Cincinnati

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月10日

初级完成 (估计的)

2030年8月1日

研究完成 (估计的)

2030年8月1日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R01MH139504 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

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

IPD 共享访问标准

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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