Clinical trial NCT05810636: Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder
Official title: Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students from 1st grade to 12th grade who are eligible based on the criteria.

Brief summary: Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Clinical diagnosis of this disorder depends of history taking, parent report, and questionnaire. Attention test such as continuous performance test can provide quantitative measurement on attention deficits; however, there is a lack of objective tool to quantify the activity level. This study aims to assess activity level in children with ADHD. We plan to recruit 50 children with ADHD and 50 neurotypical children. The activity level measured by wearable device will be compared between ADHD and neurotypical children. The correlation between behavior rating on questionnaire and quantitative data measured by wearable device will be analyzed.


Eligibility criteria: ADHD group:

Inclusion criteria:

* DSM-5 Attention-deficit hyperactivity disorder
* 7\~18 years old
* Willing to carry smartwatch and smartphone most of the time during one-month study period

Exclusion criteria:

* Comorbid with major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
* Unable to use smartwatch and smartphone

Neurotypical group:

Inclusion criteria:

* 7\~18 years old without a diagnosis of Attention-deficit hyperactivity disorder
* Willing to carry smartwatch and smartphone most of the time during one-month study period

Exclusion criteria:

* Have a diagnosis of major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
* Unable to use smartwatch and smartphone

Primary outcomes:
measure: Acceleration
timeFrame: 24 hours for 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
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