Clinical trial NCT05846815: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Lead sponsor: Peili Vision Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 134
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

ADHD group

The Inclusion criteria:

1. Signed informed consent (by guardian and a child)
2. Age of 8-13 at the time of consent
3. ADHD set by a licensed physician
4. Native language Finnish / Fluent Finnish language

TD group

The Inclusion criteria:

1. Signed informed consent (by guardian and child)
2. Age of 8-13 at the time of the consent
3. Native language Finnish / Fluent Finnish language

Exclusion Criteria:

ADHD group

1. Any diseases of the nervous system (ICD-10, G00-G99)
2. Mental and behavioural disorders due to psychoactive substance use (F10-F19)
3. Schizophrenia, schizotypal and delusional disorders (F20 - F29)
4. Acute severe depression or mania / hypomania (F30, F32, F33)
5. Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
6. Severe mental retardation (F72)
7. Disorders of psychological development (F80, F81, F83, F84)
8. Medication taken for ADHD (methylphenidate, lisdexamfetamine) on the test day (24 hour wash out)
9. Atomoxetine, guanfacine
10. 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

1. Set ADHD diagnosis.
2. Ongoing process related to setting an ADHD diagnosis, according to guardian's questionnaire.
3. Any diseases of the nervous system (ICD-10, G00-G99)
4. Mental and behavioural disorders due to psychoactive substance use (F10-F19)
5. Schizophrenia, schizotypal and delusional disorders (F20 - F29)
6. Acute severe depression or mania / hypomania (F30, F32, F33)
7. Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
8. Severe mental retardation (F72)
9. Disorders of psychological development (F80, F81, F83, F84)
10. Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision)

Primary outcomes:
measure: ARVO and CPT 3 neuropsychiatric indicators (NPIs)
timeFrame: At Visit 1 test event (four weeks after V0 enrollment)
measure: Children SSQ score
timeFrame: At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test
Secondary outcomes:
measure: ARVO and CPT 3 neuropsychiatric indicators (NPIs)
timeFrame: Visit 1 test event (four weeks after V0 enrollment)
measure: ARVO NPIs mean score and ADHR-RS for parent score
timeFrame: Visit 1 test event (four weeks after V0 enrollment)
measure: Smileyometer and Fun Sorter
timeFrame: Visit 1 test event (four weeks after V0 enrollment)
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Pro Neuron Oy
Study officials:
affiliation: Pro Neuron Oy
name: Sami Leppämäki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: