NCT06810180

Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD

Recruiting now NA Last updated 9 March 2026

What this trial tests

NA trial testing Go/No-Go Task in Attention Deficit Hyperactivity Disorder (ADHD) in 200 participants. Currently enrolling.

Timeline

17 June 2025

Primary endpoint
30 April 2030

31 March 2031

Quick facts

Lead sponsor	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	200
Start date	17 June 2025
Primary completion	30 April 2030
Estimated completion	31 March 2031
Sites	2 locations across United States

Drugs / interventions tested

• Go/No-Go Task
• Delay discounting task
• Mirror Tracing Persistence Task
• Spatial Span
• Stop Signal Task
• Flanker task

Conditions studied

• Attention Deficit Hyperactivity Disorder (ADHD) — all drugs for Attention Deficit Hyperactivity Disorder (ADHD) →
• Sleep — all drugs for Sleep →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Who can join

Adults 8 to 12, any sex, with Attention Deficit Hyperactivity Disorder (ADHD) or Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Attention deficit/hyperactivity disorder (ADHD) can present differently in individuals, with some individuals having difficulty with attentional control, hyperactivity, impulsivity, emotion dysregulation, and/or neurobehavioral functioning. The factors contributing to these different presentations remain unclear, but altered patterns of physical activity, sleep, and circadian rest/activity rhythms may play a key role.

The goal of this study is to leverage wearable technology (i.e., a wristband) to investigate the relationships between physical activity during the day, sleep patterns and disturbances, and 24-hour circadian rest/activity rhythms with differences in ADHD symptoms, emotion dysregulation, and related brain and behavioral features of attention-deficit/hyperactivity disorder (ADHD). The investigators hope this study will help improve assessment and intervention for individuals with ADHD by understanding how these factors relate to ADHD symptom expression and associated brain differences in ADHD.

Participants taking stimulant medication must withhold stimulant medication 24 hours before their research appointment and the morning of their research appointment. Stimulant medication may be restarted after the appointment is complete.

Participation in this study will require children to complete an initial 2-hour research appointment, two (2) weeks of activity and sleep monitoring at home using a wearable wristband and answering questions sent to a smartphone, and a second 4-hour research appointment after the 2-week period.

During the first research appointment, children will complete a cognitive assessment and a practice magnetic resonance imaging (MRI) scan. Parents/legal guardians will participate in the 30-45-minute sleep device training session with one of the research staff.

During the two weeks of activity/sleep monitoring at home, parents and children will answer questions about their sleep routine, ADHD symptoms, and emotional responding each morning and evening. Parents will be asked to install a questionnaire application on their smartphone. A prompt will be sent to their smartphone multiple times per day reminding parents to complete the brief assessment.

After the 2-week period, children will complete a 4-hour research appointment. During this research appointment, children will complete a 60-minute MRI scan and computer-based activities that assess cognitive skills, reward-based decision-making, and frustration tolerance. At the end of the research appointment, children will return the device to our research team. Parents may delete the questionnaire application from their phone at the end of the research appointment.

Participation will also require parents/legal guardians to complete questionnaires about their child. Questionnaires will be provided to the primary caregiver by email or at the beginning of their child's first research appointment. Parents agree to complete and return the questionnaires within one month of their child's research appointment.

Parents may be provided with additional questionnaires to give to their child's primary schoolteacher. This information is collected to better understand children's abilities, behavior, strengths, and weaknesses.

There are minimal risks associated with this study. Risks include fatigue, boredom, and mild discomfort.

There is no cost to participating in this study.

There is no direct benefit to participants for participating in this study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.