Attention Deficit Disorder With HyperactivityNCT05846815
Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children
A study testing ARVO 2.0 WEB and Conners Continuous Performance Test 3rd Edition™ (CPT 3) in people with Attention Deficit Disorder With Hyperactivity, run by Peili Vision Ltd. at 1 site in Finland.
Trial summary
Clinical investigation is aimed to assess the performance and safety of web-based ARVO 2.0, for evaluating possible Attention-Deficit/Hyperactive Disorder (ADHD) symptoms in children. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- ARVO 2.0 WEB and Conners Continuous Performance Test 3rd Edition™ (CPT 3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFinland
- Study dates
- 6 Nov 2023to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ADHD group
- The Inclusion criteria:
- Signed informed consent (by guardian and a child)
- Age of 8-13 at the time of consent
- ADHD set by a licensed physician
- Native language Finnish / Fluent Finnish language
Show all 11Show fewer
- TD group
- The Inclusion criteria:
- Signed informed consent (by guardian and child)
- Age of 8-13 at the time of the consent
- Native language Finnish / Fluent Finnish language
Who cannot join
- ADHD group
- Any diseases of the nervous system (ICD-10, G00-G99)
- Mental and behavioural disorders due to psychoactive substance use (F10-F19)
- Schizophrenia, schizotypal and delusional disorders (F20 - F29)
- Acute severe depression or mania / hypomania (F30, F32, F33)
- Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
Show all 22Show fewer
- Severe mental retardation (F72)
- Disorders of psychological development (F80, F81, F83, F84)
- Medication taken for ADHD (methylphenidate, lisdexamfetamine) on the test day (24 hour wash out)
- Atomoxetine, guanfacine
- Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision) Diagnosis search completeness criteria: Diagnosis present/absent in patient registry Kanta.
- TD group
- Set ADHD diagnosis.
- Ongoing process related to setting an ADHD diagnosis, according to guardian's questionnaire.
- Any diseases of the nervous system (ICD-10, G00-G99)
- Mental and behavioural disorders due to psychoactive substance use (F10-F19)
- Schizophrenia, schizotypal and delusional disorders (F20 - F29)
- Acute severe depression or mania / hypomania (F30, F32, F33)
- Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
- Severe mental retardation (F72)
- Disorders of psychological development (F80, F81, F83, F84)
- Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children. Prospective, Controlled Clinical Investigation
Clinical investigation is aimed to assess the performance and safety of web-based ARVO 2.0, for evaluating possible Attention-Deficit/Hyperactive Disorder (ADHD) symptoms in children. Possible ADHD symptoms are recorded by using specific predetermined neurocognitive performance indicators (NPI's), derived during/from the game.
Results of ARVO are compared to the Conners Continuous Performance Test 3rd Edition™ (CPT 3) that is a task-oriented, automated 14-minute computerized assessment of attention-deficit (AD) related problems in individuals aged 8 years and older.
Performance and safety of ARVO and CPT 3 are compared in two clinical investigation populations, 8-13 years old ADHD children and typically developing (TD) children of the same age. Test are performed by the subject while monitoring adult supervises safety of the use.
- Being tested
- ARVO 2.0 WEB, Conners Continuous Performance Test 3rd Edition™ (CPT 3)
- Keywords
- ADHD
- 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.
ARVO 2.0 WEBDevice
Medical device software where the subject navigates in a virtual apartment, with the goal of performing the tasks given by a cartoon dragon character. The child is asked to perform the subtasks in the given order, except for the subtasks to be completed at a certain time or after a certain sound cue, but the completion order does not influence the scoring. One task scenario lasts until all subtasks are correctly performed or until the time limit of 60 s is reached.
The classification whether the subject belong to typically developed population is based on quantitative neurological performance indicators produced during the game. However, even if the activity performed is differential diagnostics, ARVO does not create any medical diagnosis. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed.
Conners Continuous Performance Test 3rd Edition™ (CPT 3)Other
Subjects are required to respond by pressing the spacebar or the appropriate key on the mouse when any letter other than the letter "X" appears on the monitor. The Conners CPT 3 presents 14-minute, 360 scored stimuli trials (i.e., individual letters) on the screen, with 1, 2, or 4 sec. between the presentation of letters (i.e., the interstimulus interval; ISI). The 360 trials are divided into 6 blocks, with 3 sub-blocks each consisting of 20 trials. Each block lasts approximately 2 min and 20 sec. Scores and Score Dimensions of Attention Measured: Inattentiveness, Impulsivity, Sustained Attention and Vigilance. The Conners CPT 3 produces computer-generated reports that describe the respondent's performance.
It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed
| Study group | Role | What they receive |
|---|---|---|
| TD | Experimental | Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed) Receives: Device: ARVO 2.0 WEB; Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3) |
| ADHD | Experimental | Children of 8-13 years of age with previously diagnosed ADHD symptoms Receives: Device: ARVO 2.0 WEB; Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC)
Measured: At Visit 1 test event (four weeks after V0 enrollment)
Children SSQ score
To confirm that ARVO is safe as defined by Simulator Sickness Score (SSQ) value 0, 1, or 2.
Measured: At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test
Secondary outcomes (3)
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
To confirm that ARVO is equivalent to CPT 3 regarding individual NPIs ability to differentiate ADHD and TD groups
Measured: Visit 1 test event (four weeks after V0 enrollment)
ARVO NPIs mean score and ADHR-RS for parent score
To confirm that ARVO is equivalent to ADHD-RS regarding concurrent validity (correlation)
Measured: Visit 1 test event (four weeks after V0 enrollment)
Smileyometer and Fun Sorter
To confirm that ARVO is superior to CPT 3 regarding use experience
Measured: Visit 1 test event (four weeks after V0 enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start6 Nov 2023
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, interventional, case control clinical investigation. Comparison of groups. Equivalence study. Intervention model: cross-over assignment both groups are given both ARVO and Conners Continuous Performance Test 3rd Edition™ (CPT 3) tests. Allocation: Propensity matching is used to ensure inter-group homogeneity in background variable with possible interaction effect to ARVO and CPT 3 score. Propensity matching: age and sex.
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peili Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sami Leppämäki, MD, PhD, Principal investigator, Pro Neuron Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846815
- Sponsor's protocol ID
- Arvo-001
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By utilizing the data collected in this clinical investigation, the suitability of the web browser version of ARVO test to identify ADHD will be evaluated by metrics including number of correctly performed tasks, task efficiency, navigation efficiency, number of functions, and mouse movement speed. Additionally, it will be evaluated whether other metrics that are central to the assessment of ADHD can be identified from the collected data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children. Prospective, Controlled Clinical Investigation
- ClinicalTrials.gov ID
- NCT05846815
- Acronym / sponsor ID
- Arvo-001
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Peili Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 6 May 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.
Clinical investigation is aimed to assess the performance and safety of web-based ARVO 2.0, for evaluating possible Attention-Deficit/Hyperactive Disorder (ADHD) symptoms in children. Possible ADHD symptoms are recorded by using specific predetermined neurocognitive performance indicators (NPI's), derived during/from the game.
Results of ARVO are compared to the Conners Continuous Performance Test 3rd Edition™ (CPT 3) that is a task-oriented, automated 14-minute computerized assessment of attention-deficit (AD) related problems in individuals aged 8 years and older.
Performance and safety of ARVO and CPT 3 are compared in two clinical investigation populations, 8-13 years old ADHD children and typically developing (TD) children of the same age. Test are performed by the subject while monitoring adult supervises safety of the use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, interventional, case control clinical investigation. Comparison of groups. Equivalence study. Intervention model: cross-over assignment both groups are given both ARVO and Conners Continuous Performance Test 3rd Edition™ (CPT 3) tests. Allocation: Propensity matching is used to ensure inter-group homogeneity in background variable with possible interaction effect to ARVO and CPT 3 score. Propensity matching: age and sex.
| Arm | Type | Receives |
|---|---|---|
| TD | Experimental | Device: ARVO 2.0 WEB, Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed) |
| ADHD | Experimental | Device: ARVO 2.0 WEB, Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)Children of 8-13 years of age with previously diagnosed ADHD symptoms |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- ADHD group
- Signed informed consent (by guardian and a child)
- Age of 8-13 at the time of consent
- ADHD set by a licensed physician
- Native language Finnish / Fluent Finnish language
Key exclusion criteria (22 listed)
- ADHD group
- Any diseases of the nervous system (ICD-10, G00-G99)
- Mental and behavioural disorders due to psychoactive substance use (F10-F19)
- Schizophrenia, schizotypal and delusional disorders (F20 - F29)
- Acute severe depression or mania / hypomania (F30, F32, F33)
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 |
|---|---|---|
| ARVO 2.0 WEBMedical device software where the subject navigates in a virtual apartment, with the goal of performing the tasks given by a cartoon dragon character. The child is asked to perform the subtasks in the given order, except for the subtasks to be completed at a certain time or after a certain sound cue, but the completion order does not influence the scoring. One task scenario lasts until all subtasks are correctly performed or until the time limit of 60 s is reached. The classification whether the subject belong to typically developed population is based on quantitative neurological performance indicators produced during the game. However, even if the activity performed is differential diagnostics, ARVO does not create any medical diagnosis. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed. | Device | ADHD, TD |
| Conners Continuous Performance Test 3rd Edition™ (CPT 3)Subjects are required to respond by pressing the spacebar or the appropriate key on the mouse when any letter other than the letter "X" appears on the monitor. The Conners CPT 3 presents 14-minute, 360 scored stimuli trials (i.e., individual letters) on the screen, with 1, 2, or 4 sec. between the presentation of letters (i.e., the interstimulus interval; ISI). The 360 trials are divided into 6 blocks, with 3 sub-blocks each consisting of 20 trials. Each block lasts approximately 2 min and 20 sec. Scores and Score Dimensions of Attention Measured: Inattentiveness, Impulsivity, Sustained Attention and Vigilance. The Conners CPT 3 produces computer-generated reports that describe the respondent's performance. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed | Other | ADHD, TD |
Primary outcome
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
Time frame: At Visit 1 test event (four weeks after V0 enrollment)
To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC)
Children SSQ score
Time frame: At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test
To confirm that ARVO is safe as defined by Simulator Sickness Score (SSQ) value 0, 1, or 2.
3 secondary outcomes
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
Time frame: Visit 1 test event (four weeks after V0 enrollment)
ARVO NPIs mean score and ADHR-RS for parent score
Time frame: Visit 1 test event (four weeks after V0 enrollment)
Smileyometer and Fun Sorter
Time frame: Visit 1 test event (four weeks after V0 enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Yes. By utilizing the data collected in this clinical investigation, the suitability of the web browser version of ARVO test to identify ADHD will be evaluated by metrics including number of correctly performed tasks, task efficiency, navigation efficiency, number of functions, and mouse movement speed. Additionally, it will be evaluated whether other metrics that are central to the assessment of ADHD can be identified from the collected data.
Related trials for Attention Deficit Disorder With Hyperactivity
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
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. This study is not recruiting at the moment.
Sami Leppämäki, MD, PhD principal investigator
Pro Neuron Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARVO 2.0 WEB and Conners Continuous Performance Test 3rd Edition™ (CPT 3) in people with Attention Deficit Disorder With Hyperactivity, run by Peili Vision Ltd. at 1 site in Finland.
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 11 inclusion and 22 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: finished, as of the sponsor's last update on 4 Sep 2024. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ARVO and CPT 3 neuropsychiatric indicators (NPIs) (time frame: At Visit 1 test event (four weeks after V0 enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2024.