NCT05846815

Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children

Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children. Prospective, Controlled Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Peili Vision Ltd. · Industry
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DEVICE	ARVO 2.0 WEB	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.
OTHER	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

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-08-14
• Completion: 2024-08-14
• First posted: 2023-05-06
• Last updated: 2024-09-04

Locations

1 site across 1 country: Finland