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

NCT07684417 | Not Yet Recruiting

• 1 other identifier: R01MH139504
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Daily throughout each participant's involvement in the study, up to 3 weeks

Secondary Outcomes (6)

• Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety)

  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

  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

  Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits.

• Sleep Period Duration

  Nightly throughout study participation (around 3 weeks)

• Inattention

  Twice daily during weeks 2 and 3 of study participation.

Study Arms (2)

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).

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).

Behavioral: Misaligned sleep extension

Interventions

Aligned sleep extension BEHAVIORAL

Timing of extended sleep condition is randomly assigned to fit with participant's chronotype

Aligned Sleep Extension

Misaligned sleep extension BEHAVIORAL

Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype

Misaligned Sleep Extension

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Non-traditional school setting (morning-afternoon Monday-Friday).
• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Dean Beebe, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Stephen Becker, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean Beebe, Ph.D

CONTACT

513-636-3489; dean.beebe@cchmc.org

Stephen Becker, Ph.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)