NCT05835336

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

A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adolescents.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: VIZO Specs Ltd · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• ADHD

Interventions

Type	Name	Description
DEVICE	VIZO Glasses	Eyeglasses with personalized peripheral retinal stimuli

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-07-06
• Completion: 2023-07-06
• First posted: 2023-04-28
• Last updated: 2025-03-24
• Results posted: 2025-03-07

Locations

1 site across 1 country: Israel