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Enrolling by invitationNCT05810636Updated Jul 31, 2026

Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

An observational study in Attention Deficit Disorder With Hyperactivity, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

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Conditions studied

  • Attention Deficit Disorder With Hyperactivity
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's planned enrollment of 200 is above the median of 127 across 267 observational studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
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.

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

Interventions

  • DeviceGarmin Vivosmart wearable device

    Wearing smartwatches to collect data

06

What researchers measure

Primary outcomes

  1. Acceleration

    Arm Acceleration

    Time frame: 24 hours for 30 days

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Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 10048, Taiwan
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References and documents

Publications

  • Burton C, McKinstry B, Szentagotai Tatar A, Serrano-Blanco A, Pagliari C, Wolters M. Activity monitoring in patients with depression: a systematic review. J Affect Disord. 2013 Feb 15;145(1):21-8. doi: 10.1016/j.jad.2012.07.001. Epub 2012 Aug 4. PubMed 22868056 ↗
  • Cho CH, Lee T, Kim MG, In HP, Kim L, Lee HJ. Mood Prediction of Patients With Mood Disorders by Machine Learning Using Passive Digital Phenotypes Based on the Circadian Rhythm: Prospective Observational Cohort Study. J Med Internet Res. 2019 Apr 17;21(4):e11029. doi: 10.2196/11029. PubMed 30994461 ↗
  • Couronne R, Probst P, Boulesteix AL. Random forest versus logistic regression: a large-scale benchmark experiment. BMC Bioinformatics. 2018 Jul 17;19(1):270. doi: 10.1186/s12859-018-2264-5. PubMed 30016950 ↗
  • Dogan E, Sander C, Wagner X, Hegerl U, Kohls E. Smartphone-Based Monitoring of Objective and Subjective Data in Affective Disorders: Where Are We and Where Are We Going? Systematic Review. J Med Internet Res. 2017 Jul 24;19(7):e262. doi: 10.2196/jmir.7006. PubMed 28739561 ↗
  • Gau SS, Chen SJ, Chou WJ, Cheng H, Tang CS, Chang HL, Tzang RF, Wu YY, Huang YF, Chou MC, Liang HY, Hsu YC, Lu HH, Huang YS. National survey of adherence, efficacy, and side effects of methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan. J Clin Psychiatry. 2008 Jan;69(1):131-40. doi: 10.4088/jcp.v69n0118. PubMed 18312048 ↗
  • Gau SS, Lin CH, Hu FC, Shang CY, Swanson JM, Liu YC, Liu SK. Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, Version IV Scale-Teacher Form. J Pediatr Psychol. 2009 Sep;34(8):850-61. doi: 10.1093/jpepsy/jsn133. Epub 2008 Dec 12. PubMed 19074488 ↗
  • Gau SS, Shang CY, Liu SK, Lin CH, Swanson JM, Liu YC, Tu CL. Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, version IV scale - parent form. Int J Methods Psychiatr Res. 2008;17(1):35-44. doi: 10.1002/mpr.237. PubMed 18286459 ↗
  • Leikauf JE, Correa C, Bueno AN, Sempere VP, Williams LM. StopWatch: Pilot study for an Apple Watch application for youth with ADHD. Digit Health. 2021 Apr 1;7:20552076211001215. doi: 10.1177/20552076211001215. eCollection 2021 Jan-Dec. PubMed 33868703 ↗
  • Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872. PubMed 21652563 ↗
  • Marzano L, Bardill A, Fields B, Herd K, Veale D, Grey N, Moran P. The application of mHealth to mental health: opportunities and challenges. Lancet Psychiatry. 2015 Oct;2(10):942-8. doi: 10.1016/S2215-0366(15)00268-0. Epub 2015 Sep 29. PubMed 26462228 ↗
  • 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. PubMed 28973116 ↗
  • Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007 Jun;164(6):942-8. doi: 10.1176/ajp.2007.164.6.942. PubMed 17541055 ↗
  • Reinertsen E, Clifford GD. A review of physiological and behavioral monitoring with digital sensors for neuropsychiatric illnesses. Physiol Meas. 2018 May 15;39(5):05TR01. doi: 10.1088/1361-6579/aabf64. PubMed 29671754 ↗
  • Simon V, Czobor P, Balint S, Meszaros A, Bitter I. Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis. Br J Psychiatry. 2009 Mar;194(3):204-11. doi: 10.1192/bjp.bp.107.048827. PubMed 19252145 ↗
  • Swanson JM, Kraemer HC, Hinshaw SP, Arnold LE, Conners CK, Abikoff HB, Clevenger W, Davies M, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Jensen PS, March JS, Newcorn JH, Owens EB, Pelham WE, Schiller E, Severe JB, Simpson S, Vitiello B, Wells K, Wigal T, Wu M. Clinical relevance of the primary findings of the MTA: success rates based on severity of ADHD and ODD symptoms at the end of treatment. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):168-79. doi: 10.1097/00004583-200102000-00011. PubMed 11211365 ↗
  • Tazawa Y, Wada M, Mitsukura Y, Takamiya A, Kitazawa M, Yoshimura M, Mimura M, Kishimoto T. Actigraphy for evaluation of mood disorders: A systematic review and meta-analysis. J Affect Disord. 2019 Jun 15;253:257-269. doi: 10.1016/j.jad.2019.04.087. Epub 2019 Apr 22. PubMed 31060012 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05810636
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Apr 12, 2023
Start date
Feb 16, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 31, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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