Back to resultsAssessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
ARVO 2.0 WEB
Conners Continuous Performance Test 3rd Edition™ (CPT 3)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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) 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)
Sites / Locations
- Pro Neuron Oy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TD
ADHD
Arm Description
Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed)
Children of 8-13 years of age with previously diagnosed ADHD symptoms
Outcomes
Primary Outcome Measures
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC)
Children SSQ score
To confirm that ARVO is safe as defined by Simulator Sickness Score (SSQ) value 0, 1, or 2.
Secondary Outcome Measures
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
ARVO NPIs mean score and ADHR-RS for parent score
To confirm that ARVO is equivalent to ADHD-RS regarding concurrent validity (correlation)
Smileyometer and Fun Sorter
To confirm that ARVO is superior to CPT 3 regarding use experience
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05846815
Brief Title
Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children
Official Title
Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children. Prospective, Controlled Clinical Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peili Vision Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TD
Arm Type
Experimental
Arm Description
Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed)
Arm Title
ADHD
Arm Type
Experimental
Arm Description
Children of 8-13 years of age with previously diagnosed ADHD symptoms
Intervention Type
Device
Intervention Name(s)
ARVO 2.0 WEB
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conners Continuous Performance Test 3rd Edition™ (CPT 3)
Intervention Description
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
Primary Outcome Measure Information:
Title
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
Description
To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC)
Time Frame
At Visit 1 test event (four weeks after V0 enrollment)
Title
Children SSQ score
Description
To confirm that ARVO is safe as defined by Simulator Sickness Score (SSQ) value 0, 1, or 2.
Time Frame
At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test
Secondary Outcome Measure Information:
Title
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
Description
To confirm that ARVO is equivalent to CPT 3 regarding individual NPIs ability to differentiate ADHD and TD groups
Time Frame
Visit 1 test event (four weeks after V0 enrollment)
Title
ARVO NPIs mean score and ADHR-RS for parent score
Description
To confirm that ARVO is equivalent to ADHD-RS regarding concurrent validity (correlation)
Time Frame
Visit 1 test event (four weeks after V0 enrollment)
Title
Smileyometer and Fun Sorter
Description
To confirm that ARVO is superior to CPT 3 regarding use experience
Time Frame
Visit 1 test event (four weeks after V0 enrollment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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)
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Marttila, MSc
Phone
+358408287074
Email
hanna.marttila@labquality.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sami Leppämäki, MD, PhD
Organizational Affiliation
Pro Neuron Oy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pro Neuron Oy
City
Espoo
ZIP/Postal Code
02650
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Uurainen, MSc
Phone
+358 400 601 991
Email
arvo@proneuron.fi
First Name & Middle Initial & Last Name & Degree
Sami Leppämäki, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
2024-2030
IPD Sharing Access Criteria
Scientific research as defined in the Clinical Investigation Plan and supporting documents.
Learn more about this trial
Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children
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