Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

March 31, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei city, Taiwan, 10048
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Students from 1st grade to 12th grade who are eligible based on the criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Device: Garmin Vivosmart wearable 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
Device: Garmin Vivosmart wearable device
Wearing smartwatches to collect data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceleration
Time Frame: 24 hours for 30 days
Arm Acceleration
24 hours for 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202110059RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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