A Novel Device for the Management of ADHD

VIZO Specs

Status: Completed

Conditions: ADHD

Treatments: Device: VIZO Glasses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05777785

VIZO_003

Details and patient eligibility

About

This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.

Full description

This study was designed as a pilot single-center, open-label study of 2 months treatment. 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 Conners Continuous Performance Test-3, the Adult ADHD Self-Report Scale (ASRS), Behavior Rating Inventory of Executive Function Adults (BRIEF-A), and Clinical Global Impression-Improvement (CGI-I) .

Enrollment: 108 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history of primary ADHD diagnosis by certified clinicians
• Age 18-40 y
• 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)
• Neurofeedback, cognitive training

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Active

Experimental group

Description:

VIZO Glasses- personalized

Treatment:

Device: VIZO Glasses