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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06810180
Enrollment
200
Registered
2025-02-05
Start date
2025-06-17
Completion date
2031-03-31
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD), Sleep, Physical Activity

Keywords

ADHD, Circadian Rhythms, Ecological Momentary Assessment (EMA)

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.

Interventions

BEHAVIORALGo/No-Go Task

A computerized test in which participants are presented with red and green spaceship stimuli. They are told to press the spacebar in response to green spaceships (80% of trials) and withhold their response to red spaceships (20% of trials).

BEHAVIORALDelay discounting task

Participants make decisions between smaller, immediate rewards and larger, delayed rewards. The amount of the immediate reward and delay time are manipulated to identify individual delay discounting curves, or how the reward value decreases as a function of delay.

BEHAVIORALMirror Tracing Persistence Task

A computerized test in which participants trace a star line drawing with a computer cursor using a trackpad with reversed directional controls. There are increasing levels of difficulty with participants being told they could quit the task during the very hard third star that they try to trace.

BEHAVIORALSpatial Span

Participants are instructed to attend to a computer screen to keep track of the order in which a happy face stimuli appears in a sequence of boxes positioned on the screen. They are presented with 2 trials at each level of difficulty, increasing from 2 stimuli by 1 additional stimuli per trial until they respond incorrectly for both trials within a level. There are two task conditions, forward and backward span, with the participant responding in the reverse order that the stimuli were presented for backward span.

A computerized test in which participants are presented with a right or left facing arrow and are instructed to press a response button indicating the direction of the arrow. On 25% of the trials, an auditory beep is presented (i.e., stop signal) following the onset of the arrow (i.e., go signal) and participants are instructed to withhold their response when they hear the stop signal.

BEHAVIORALFlanker task

A computerized test in which a group of arrows are presented on the screen with the central arrow (target) pointing in the same/opposite direction as the 4 surrounding arrows (flankers). Participants are instructed to respond as quickly and accurately as possible to the central target arrow.

Sponsors

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Total Activity Counts (TAC)Two-week, real-time period of at-home activity monitoringUsing an actigraph, this study will collect daily physical activity levels of children. The actigraphic measure, total activity counts (TAC), will capture the number of times a child engages in periods of physical activity during the day and night.
Children's Sleep Health Questionnaire (CSHQ) Total ScoreWithin six months prior to the first research appointment.Sleep quality will be measured using the total score from the parent reported questionnaire asking about sleep duration, sleep disturbances, and sleep quality.
ADHD-related SymptomsWithin six months prior to the first research appointment.Parents will complete a diagnostic interview and rating scales reporting on ADHD symptoms, cognitive disengagement syndrome, irritability and emotion dysregulation.
Mean Fractional Anisotropy (FA)Completed during the MRI scan on Day 15Mean fractional anisotropy (FA) is a structural connectivity diffusion weighted imaging outcomes. It is a value that represents the overall degree of directional diffusion within that area, with higher values indicating more organized/connectivity, aligned white matter fibers, and lower values suggesting less organized fibers. Mean fractional anisotropy (FA) will be assessed in six fronto-subcortical tracts of interest including (1) OFC-limbic striatum, (2) dlPFC-executive striatum, (3) ACC-limbic striatum, (4) ACC-executive striatum, (5) OFC- and (6) ACC-amygdala in each hemisphere.
Stop Signal Reaction TimeTask will be completed on Day 15Measure of inhibitory control from the stop signal task based on the mean stop signal delay and mean go reaction time.
Congruency Effect on Reaction TimeTask will be completed on Day 15Difference in reaction time on correct response trials from the flanker task with congruent versus incongruent flanking stimuli.
Commission ErrorsTask will be completed on Day 15Percentage of incorrect responses on no-go trials during the go/no-go task.
Backward Span AccuracyTask will be completed on Day 15Total number of correct trials for the digit and spatial span tasks (separately), backwards span condition
Delay Discounting Area Over the Curve (AOC)Task will be completed on Day 15Area over the curve (AOC) is a measure of the extent to which an individual discounts a reward as a function of delay. We will assess this measure during delay discounting tasks with different types of rewards (money and game time).
Mirror Tracing Persistance Task Latency to QuitTask will be completed on Day 15During the very hard star condition of the MTPT, participants may choose to quit the task. This is the amount of time that passes until they quit the task.
Total Sleep Time (TST)Two-week, real-time period of at-home activity monitoringTotal sleep time (TST) will be collected using a wearable actigraph wristband. This variable is reported in minutes.
Wake After Sleep Onset (WASO)Two-week, real-time period of at-home activity monitoringThis variable is collected using a wearable actigraph wristband. This variable is reported in minutes.
Sleep EfficiencyTwo-week, real-time period of at-home activity monitoringThis variable is collected using a wearable actigraph wristband. This variable is the proportion of time-in-bed spent asleep compared to the total time spent in bed.
Sleep Onset Latency (SOL)Two-week, real-time period of at-home activity monitoringThis variable is collected using a wearable actigraph wristband. This variable captures how long it takes for a child to fall asleep once they are in bed.
Intra-daily VariabilityTwo-week, real-time period of at-home activity monitoringThis variable is collected using a wearable actigraph wristband. Intra-daily variability is a measure of how fragmented a person's rest-activity rhythm (RAR) is over the course of a 24-hour period. quantifies the amount of switching between high and low activity levels within a day. Higher IV values indicate greater fragmentation, which can be a sign of frequent napping or inefficient sleep.
Midline Estimating Statistic of Rhythm (MESOR)Two-week, real-time period of at-home activity monitoringThis variable is collected using a wearable actigraph wristband. Mesor is a rhythm-adjusted mean that describes the value around which a fitted wave oscillates. The wave is dictated by the intensity of physical activity over a 24-hour period.
Functional connectivity Z-scoresCompleted during an MRI scan on Day 15Functional connectivity will be examined among the same 6 fronto-subcortical tracts of interest including (1) OFC-limbic striatum, (2) dlPFC-executive striatum, (3) ACC-limbic striatum, (4) ACC-executive striatum, (5) OFC- and (6) ACC-amygdala in each hemisphere, as well as within- and between-network connectivity of the default mode network with the frontoparietal, salience, and affective networks. The primary measure of functional connectivity will be derived by correlating the average time series across ROIs and converting the correlations to z scores using Fisher's transform.

Countries

United States

Contacts

CONTACTKeri S Rosch, PhD in Clinical Psychology
Rosch@KennedyKrieger.org443-923-9465
CONTACTAlyssa C DeRonda, MS in Experimental Psychology
deronda@kennedykrieger.org443-923-9258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026