NCT05777785

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 25, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

February 15, 2023

Results QC Date

January 26, 2025

Last Update Submit

March 23, 2025

Conditions

ADHD

Keywords

ADHDPeripheral Retinal Stimulationnon-pharmacological

Outcome Measures

Primary Outcomes (2)

  • Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up

    The Adult ADHD Self-Report Scale (ASRS) is a self-report instrument that comprises eighteen items that correspond with the DSM-V-TR criteria for ADHD. Subjects are asked to rate 18 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 72, based on the sum of all 18 questions. Higher scores mean more symptoms and higher ADHD's impairments. Lower values represent better outcomes. The ASRS has two subscales that can be used to identify ADHD subtypes - Inattentiveness and Hyperactivity/Impulsivity. Each subscale contains 9 questions.

    Baseline, 2 months

  • Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up

    The inattentiveness sub-scale of the ASRS measures difficulties with focusing on details, organisation, remembering appointments, making careless mistakes, and concentration. It includes 9 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 36, based on the sum of all questions. Higher scores mean more symptoms and higher inattentiveness' impairments.

    Baseline, 2 months

Secondary Outcomes (3)

  • Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up

    2 months

  • Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up

    Baseline, 2 months

  • Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up

    Baseline, 2 months

Study Arms (1)

Active

EXPERIMENTAL

VIZO Glasses- personalized

Device: VIZO Glasses

Interventions

VIZO GlassesDEVICE

Eyeglasses with personalized peripheral retinal stimuli

Active

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Stern Academic College of Emek Yezreel

Haifa, Israel

Location

Related Publications (1)

  • Richter Y, Gordon C, Vainstein G, Bublil-Mor C, Geisinger D, Meital-Kfir N, Elyoseph Z. A novel intervention for treating adults with ADHD using peripheral visual stimulation. Front Psychiatry. 2023 Oct 20;14:1280440. doi: 10.3389/fpsyt.2023.1280440. eCollection 2023.

    PMID: 37928920DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Yael Richter, PhD
Organization
VIZO Specs
yaelr@vizo-o.com
972-54-7384809

Study Officials

  • Zohar Elyoseph, PhD

    Max Stern Academic College of Emek Yezreel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 21, 2023

Study Start

April 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 26, 2023

Last Updated

March 25, 2025

Results First Posted

March 25, 2025

Record last verified: 2025-03

Locations

IL(1)