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

Official title

Impact of Circadian Misalignment for Adolescents With ADHD: Observational and Mechanistic Data

Overview

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.

Interventions

• Behavioral Aligned sleep extension
  Timing of extended sleep condition is randomly assigned to fit with participant's chronotype
• Behavioral Misaligned sleep extension
  Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype

Primary outcome measures

• Caregiver- and Adolescent-Reported Symptoms of Inattention [Time frame: Daily throughout each participant's involvement in the study, up to 3 weeks]

Secondary outcome measures (6)

• 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.]
• 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.]
• 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.]
• Sleep Period Duration [Time frame: Nightly throughout study participation (around 3 weeks)]
• Inattention [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Cincinnati Children's Hospital Medical Center — Cincinnati

Identifiers

NCT: NCT07684417 · R01MH139504 · R01MH139504

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗