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

Peili Vision

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3); Device: ARVO 2.0 WEB

Study type: Interventional

Funder types: Industry

Identifiers

NCT05846815

Arvo-001

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

TD

Experimental group

Description:

Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed)

Treatment:

Device: ARVO 2.0 WEB

Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)

ADHD

Experimental group

Description:

Children of 8-13 years of age with previously diagnosed ADHD symptoms

Treatment:

Device: ARVO 2.0 WEB

Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)