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NCT05777785

A Novel Device for the Management of ADHD

Completed NA Results posted Last updated 25 March 2025
What this trial tests

NA trial testing VIZO Glasses in ADHD in 108 participants. Completed in 26 March 2023.

Timeline
1 April 2022
Primary endpoint
1 March 2023
26 March 2023

Quick facts

Lead sponsorVIZO Specs Ltd
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment108
Start date1 April 2022
Primary completion1 March 2023
Estimated completion26 March 2023
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

VIZO Specs Ltd

Who can join

Adults 18 to 40, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up Primary · Baseline, 2 months

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
GroupValue95% CI
Active39.76± 1.24
End of study
GroupValue95% CI
Active38.27± 1.31
Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up Primary · Baseline, 2 months

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
GroupValue95% CI
Active21.20± 0.69
End of study
GroupValue95% CI
Active20.22± 0.72
Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up Secondary · 2 months

Based on an interview with the participant, the clinician rates the total improvement on a 7 point scale as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.

GroupValue95% CI
Active77
Active11
Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up Secondary · Baseline, 2 months

Conners' Continuous Performance Test-3 (CPT-3) is an objective test of attention and impulsivity that has been validated in individuals aged 8 years and older. d-prime (d') is a measure of how well the respondent discriminates nontargets (i.e., the letter X) from targets (i.e., all other letters). This variable is also a signal detection statistic that measures the difference between the signal (targets) and noise (non-targets) distributions. In general, the greater the difference between the signal and noise distributions, the better the ability to distinguish non-targets and targets. CPT s

Baseline
GroupValue95% CI
Active50.03± 0.90
End of Study
GroupValue95% CI
Active47.95± 1.06
Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up Secondary · Baseline, 2 months

The Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) is a standardized measure that captures views of adults' executive functions or self-regulation in their everyday environment. Items are rated on a 3-points Likert scale of 1 ('Never') to 3 ('Often'). The Metacognition Index (MI) of the BRIEF-A reflects the individual's ability to initiate activity and generate problem-solving ideas, to sustain working memory, to plan and organize problem-solving approaches, to monitor success and failure in problem solving, and to organize one's materials and environment. The MI subs

Baseline
GroupValue95% CI
Active79.85± 1.75
End of Study
GroupValue95% CI
Active77.76± 1.75

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected during the two-month intervention period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active
Serious: 0/100 (0%)
Deaths: 0/100
Other adverse events (5 terms — click to expand)

ReactionSystemActive
HeadacheGeneral disorders
EyestrainGeneral disorders
DizzinessGeneral disorders
TirednessGeneral disorders
DiscomfortGeneral disorders

Data from ClinicalTrials.gov NCT05777785 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A novel intervention for treating adults with ADHD using peripheral visual stimulation.
    Richter Y, Gordon C, Vainstein G, Bublil-Mor C, et al · · 2023 · cited 3× · PMID 37928920 · DOI 10.3389/fpsyt.2023.1280440

Verify or expand the search:

Other trials of VIZO Glasses

Trials testing the same drug.

Other recruiting trials for ADHD

Currently open trials in the same condition.

Other VIZO Specs Ltd trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05777785.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing