Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

NCT ID: NCT05810636

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-16

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Garmin Vivosmart wearable device

Intervention Type DEVICE

Wearing smartwatches to collect data

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

Garmin Vivosmart wearable device

Intervention Type DEVICE

Wearing smartwatches to collect data

Interventions

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Garmin Vivosmart wearable device

Wearing smartwatches to collect data

Intervention Type DEVICE

Eligibility Criteria

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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


* 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

* 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:


* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 21652563 (View on PubMed)

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Reference Type BACKGROUND
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Patel MS, Foschini L, Kurtzman GW, Zhu J, Wang W, Rareshide CAL, Zbikowski SM. Using Wearable Devices and Smartphones to Track Physical Activity: Initial Activation, Sustained Use, and Step Counts Across Sociodemographic Characteristics in a National Sample. Ann Intern Med. 2017 Nov 21;167(10):755-757. doi: 10.7326/M17-1495. Epub 2017 Sep 26. No abstract available.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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202110059RINB

Identifier Type: -

Identifier Source: org_study_id

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