Clinical trial NCT06810180: Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD
Official title: Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sleep
Physical Activity
Keywords: ADHD
Circadian Rhythms
Ecological Momentary Assessment (EMA)
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll 200 8-12-year-old children either with a diagnosis of ADHD (n=100) or without a diagnosis of ADHD (controls; n=100). Male and female children are eligible.

Brief summary: 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.


Eligibility criteria: ADHD Clinical Group. Meet criteria for attention deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria.

Exclusion Criteria:

Prematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Co-occurring neurodevelopmental disorders (e.g., autism spectrum disorder, intellectual disability) Anxiety/mood disorders Active psychosis Bipolar disorder Conduct disorder Currently taking longer acting psychotropic medications that cannot be discontinued the day before research appointments

Control Group. Does not meet criteria for psychological or neuropsychological disorders Does not meet criteria for intellectual disability Does not meet criteria for a learning disorder

Exclusion Criteria:

Prematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Currently taking medications that cannot be discontinued the day before research appointments

Primary outcomes:
measure: Total Activity Counts (TAC)
timeFrame: Two-week, real-time period of at-home activity monitoring
measure: Children's Sleep Health Questionnaire (CSHQ) Total Score
timeFrame: Within six months prior to the first research appointment.
measure: ADHD-related Symptoms
timeFrame: Within six months prior to the first research appointment.
measure: Mean Fractional Anisotropy (FA)
timeFrame: Completed during the MRI scan on Day 15
measure: Stop Signal Reaction Time
timeFrame: Task will be completed on Day 15
measure: Congruency Effect on Reaction Time
timeFrame: Task will be completed on Day 15
measure: Commission Errors
timeFrame: Task will be completed on Day 15
measure: Backward Span Accuracy
timeFrame: Task will be completed on Day 15
measure: Delay Discounting Area Over the Curve (AOC)
timeFrame: Task will be completed on Day 15
measure: Mirror Tracing Persistance Task Latency to Quit
timeFrame: Task will be completed on Day 15
measure: Total Sleep Time (TST)
timeFrame: Two-week, real-time period of at-home activity monitoring
measure: Wake After Sleep Onset (WASO)
timeFrame: Two-week, real-time period of at-home activity monitoring
measure: Sleep Efficiency
timeFrame: Two-week, real-time period of at-home activity monitoring
measure: Sleep Onset Latency (SOL)
timeFrame: Two-week, real-time period of at-home activity monitoring
measure: Intra-daily Variability
timeFrame: Two-week, real-time period of at-home activity monitoring
measure: Midline Estimating Statistic of Rhythm (MESOR)
timeFrame: Two-week, real-time period of at-home activity monitoring
measure: Functional connectivity Z-scores
timeFrame: Completed during an MRI scan on Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Hugo W. Moser Research Institute at Kennedy Krieger
state: Maryland
Study officials:
References:
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