Attention Deficit Disorder With HyperactivityNCT05810636
Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Garmin Vivosmart wearable device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Feb 2022to 31 Dec 2026
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Students from 1st grade to 12th grade who are eligible based on the criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Garmin Vivosmart wearable device
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin Vivosmart wearable deviceDevice
Wearing smartwatches to collect data
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Device: Garmin Vivosmart wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceleration
Arm Acceleration
Measured: 24 hours for 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start16 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810636
- Sponsor's protocol ID
- 202110059RINB
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 22868056Cho 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 30994461Couronne 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 30016950Dogan 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 28739561Gau 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 18312048Gau 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 19074488Gau 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 18286459Leikauf 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 33868703Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.
PubMed 21652563Marzano 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 26462228Patel 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 28973116Polanczyk 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 17541055Reinertsen 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 29671754Simon 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 19252145Swanson 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05810636
- Acronym / sponsor ID
- 202110059RINB
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | Device: Garmin Vivosmart wearable deviceInclusion 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) |
| Neurotypical group | – | Device: Garmin Vivosmart wearable deviceInclusion 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Students from 1st grade to 12th grade who are eligible based on the criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garmin Vivosmart wearable deviceWearing smartwatches to collect data | Device | ADHD group, Neurotypical group |
Primary outcome
Acceleration
Time frame: 24 hours for 30 days
Arm Acceleration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 22868056Burton 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.
- Background: PubMed 30994461Cho 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.
- Background: PubMed 30016950Couronne 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.
- Background: PubMed 28739561Dogan 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.
- Background: PubMed 18312048Gau 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.
- Background: PubMed 19074488Gau 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.
- Background: PubMed 18286459Gau 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.
- Background: PubMed 33868703Leikauf 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.
- Background: PubMed 21652563Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.
- Background: PubMed 26462228Marzano 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.
- Background: PubMed 28973116Patel 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.
- Background: PubMed 17541055Polanczyk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceleration (time frame: 24 hours for 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05810636, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.