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

2026년 8월 13일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Stephen Becker, Ph.D.

연구 장소

  • 미국
    • Ohio
      • Cincinnati, Ohio, 미국, 45229
        • 모병
        • Cincinnati Children's Hospital Medical Center
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
행동: Aligned sleep extension
Timing of extended sleep condition is randomly assigned to fit with participant's chronotype
실험적: 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).
행동: Misaligned sleep extension
Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Caregiver- and Adolescent-Reported Symptoms of Inattention
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Children's Hospital Medical Center, Cincinnati

협력자

National Institute of Mental Health (NIMH)

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 10일

기본 완료 (추정된)

2030년 8월 1일

연구 완료 (추정된)

2030년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 10일

QC 기준을 충족하는 최초 제출

2026년 6월 29일

처음 게시됨 (실제)

2026년 7월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 13일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R01MH139504 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 액세스 기준

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다