Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05810636

Collaborator

(none)

200

Enrollment

Location

22.4

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Device: Garmin Vivosmart wearable device

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

Actual Study Start Date :

Feb 16, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Acceleration [24 hours for 30 days]
Arm Acceleration

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei city		Taiwan	10048

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05810636

Other Study ID Numbers:

202110059RINB

First Posted:

Apr 12, 2023

Last Update Posted:

Apr 12, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Apr 12, 2023