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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Stephen Becker, Ph.D.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver- and Adolescent-Reported Symptoms of Inattention
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH139504 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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