- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07684417
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dean Beebe, Ph.D
- Phone Number: 513-636-3489
- Email: dean.beebe@cchmc.org
Study Contact Backup
- Name: Stephen Becker, Ph.D.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Contact:
- Dean Beebe, Ph.D.
- Phone Number: 513-636-3489
- Email: dean.beebe@cchmc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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).
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Timing of extended sleep condition is randomly assigned to fit with participant's chronotype
|
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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
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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
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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
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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.
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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.
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Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.
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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)
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Nightly sleep period, defined as the simple difference between sleep onset and offset, based on a wrist-mounted accelerometer (wristwatch).
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Nightly throughout study participation (around 3 weeks)
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Inattention
Time Frame: Twice daily during weeks 2 and 3 of study participation.
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Adolescent-reported attention will me assessed via Ecological Momentary Assessment (EMA)
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Twice daily during weeks 2 and 3 of study participation.
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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.
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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.
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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.
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Collaborators and Investigators
Collaborators
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
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH139504 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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