ADHDAACTNCT07684417
Impact of Short and Mistimed Sleep on Adolescents With ADHD: The Adolescent Attention and Circadian Timing Study
A study testing Aligned sleep extension and Misaligned sleep extension in people with ADHD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Aligned sleep extension and Misaligned sleep extension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephen Becker, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Dean Beebe, Ph.D., 513-636-3489, dean.beebe@cchmc.org
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Aligned sleep extension, Misaligned sleep extension
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aligned sleep extensionBehavioural
Timing of extended sleep condition is randomly assigned to fit with participant's chronotype
Misaligned sleep extensionBehavioural
Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype
| Study group | Role | What they receive |
|---|---|---|
| Aligned Sleep Extension | Experimental | 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). Receives: Behavioral: Aligned sleep extension |
| Misaligned Sleep Extension | Experimental | 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). Receives: Behavioral: Misaligned sleep extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver- and Adolescent-Reported Symptoms of Inattention
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.
Measured: Daily throughout each participant's involvement in the study, up to 3 weeks
Secondary outcomes (6)
Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
Sleep Period Duration
Nightly sleep period, defined as the simple difference between sleep onset and offset, based on a wrist-mounted accelerometer (wristwatch).
Measured: Nightly throughout study participation (around 3 weeks)
Inattention
Adolescent-reported attention will me assessed via Ecological Momentary Assessment (EMA)
Measured: Twice daily during weeks 2 and 3 of study participation.
Inattention, as objectively measured via the NASA PVT+ application (aka Psychomotor Vigilance Test).
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Jul 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Dean Beebe, Ph.D., Principal investigator, Children's Hospital Medical Center, CincinnatiStephen Becker, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684417
- Sponsor's protocol ID
- R01MH139504
- Other IDs
- R01MH139504
- Acronym
- AACT
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per sponsor policy, primary outcome data will be shared with the NIMH Data Archive (NDA).