A Novel, Non-pharmacological, Intervention for the Management of ADHD in Adolescents

VIZO Specs

Status

Completed

Conditions

ADHD

Treatments

Device: VIZO Glasses

Study type

Interventional

Funder types

Industry

Identifiers

NCT05835336

VIZO_004

Details and patient eligibility

About

This is a 2-month study in which eligible ADHD adolescents will be provided with personalized VIZO Glasses

Full description

This is a pilot, open-label study of a 2-month treatment with VIZO Glasses. Following the enrollment, the participants will go through an adjustment process where they will be fitted with a personalized pair of VIZO Glasses. The participants will be instructed to wear the glasses throughout the day for two months. A follow-up visit at the end of the 2-month treatment will be conducted to assess the efficacy of VIZO Glasses on managing ADHD symptoms, using the ADHD Rating Scale (ADHD-RS) parent-report questionnaire, the Behavior Rating Inventory of Executive Function (BRIEF), the Conners Continuous Performance Test-3, and the Clinical Global Impression-Improvement (CGI-I). Safety will be monitored by documentation of adverse events.

Enrollment

32 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented history of primary ADHD diagnosis by certified clinicians
Age 12-17 y
Minimum total of 24 on the parent ADHD-IV Rating Scale (ADHD-RS)
Written informed consent
Able and willing to complete all required ratings and assessments

Exclusion criteria

Any current psychiatric/neurological comorbidity (e.g., epilepsy, Autism, depression, TBI, etc.), other than ADHD
ADHD Medications (stimulants, non-stimulants, other)
Undergoing Neurofeedback, cognitive training