ADHDNCT05835336

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

A study testing VIZO Glasses in people with ADHD, run by VIZO Specs Ltd at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 12 to 17 years
Conditions the study is for: ADHD
What is being tested?: VIZO Glasses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteIsrael
Study dates: 1 Apr 2022to 6 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

Max Stern Academic College of Emek Yezreel
Haifa

Other trials in Israel

About this study

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

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

Read the 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
Being tested: VIZO Glasses
Keywords: ADHD, Peripheral Retinal Stimulation, Non-pharmacological treatment, Adolescents
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VIZO GlassesDevice
Eyeglasses with personalized peripheral retinal stimuli

Study groups in NCT05835336
Study group	Role	What they receive
Active	Experimental	VIZO Glasses- personalized Receives: Device: VIZO Glasses

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up
The ADHD-RS is a parent report questionnaire that is used to aid in the diagnosis of ADHD in children ranging from ages 5-17. The questionnaire contains 18 symptom items corresponding to the DSM-V criteria for ADHD. The parent rates each symptom item on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 54. Higher scores mean more symptoms and higher ADHD impairments.
Measured: Baseline, 2-month
Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up
The Inattention subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's attention level on tasks or play activities.The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.
Measured: Baseline, 2-month
Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up
The Hyperactivity-Impulsivity subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's hyperactivity level and impulsivity level. The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.
Measured: Baseline, 2-month
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up
The Metacognition Index (MI) of the BRIEF reflects a child's ability to self-manage and monitor tasks cognitively. The subscale is composed of the Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor scales of the BRIEF. It uses a Likert-type response format ranging from 1 to 3, where 1 is never, 2 is sometimes, and 3 is often. The MI subscale includes 40-items with score ranges between 0 to 120. Higher values represent worse outcome and greater difficulties with executive functions. High scores indicate executive deficit.
Measured: Baseline, 2-month

Secondary outcomes (3)

Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up
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.
Measured: 2-month
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up
The BRIEF is a standardized measure that captures views of executive functions or self-regulation in the everyday environment. The BRIEF is composed of 86 items, where each item is rated by the parent, using a 3-point Likert scale ranging from 1 ('Never') to 3 ('Often'). Total score ranges between 86 to 258. The Global Executive Composite (GEC) is an overarching summary score that incorporates all of the BRIEF clinical scales. High scores indicate executive deficit.
Measured: Baseline, 2-month
Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up
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 scores are age and gender standardized T-scores, in which the mean is equal to 50 and the standard deviation is equal to 10. d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination). Atypical scores are higher than 60 indicating "elevated" to "very elevated" performance.
Measured: Baseline, 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20226 Jul 2023

First posted28 Apr 2023
Study start1 Apr 2022
Primary completion6 Jul 2023
Study completion6 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ADHDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05835336
Sponsor's protocol ID: VIZO_004
Status last verified: Mar 2025
First submitted: 18 Apr 2023
Last updated: 24 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ADHD trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adolescents.
ClinicalTrials.gov ID: NCT05835336
Acronym / sponsor ID: VIZO_004
Conditions: ADHD
Keywords: ADHD, Peripheral Retinal Stimulation, Non-pharmacological treatment, Adolescents
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: VIZO Specs LtdIndustry (pharma, biotech, devices)
Study start: 1 Apr 2022 (actual)
Primary completion: 6 Jul 2023 (actual)
Study completion: 6 Jul 2023 (actual)
First posted: 28 Apr 2023 (actual)
Results: Posted 7 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active	Experimental	Device: VIZO GlassesVIZO Glasses- personalized

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VIZO GlassesEyeglasses with personalized peripheral retinal stimuli	Device	Active

Primary outcome

Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up
Time frame: Baseline, 2-month
The ADHD-RS is a parent report questionnaire that is used to aid in the diagnosis of ADHD in children ranging from ages 5-17. The questionnaire contains 18 symptom items corresponding to the DSM-V criteria for ADHD. The parent rates each symptom item on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 54. Higher scores mean more symptoms and higher ADHD impairments.
Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up
Time frame: Baseline, 2-month
The Inattention subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's attention level on tasks or play activities.The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.
Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up
Time frame: Baseline, 2-month
The Hyperactivity-Impulsivity subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's hyperactivity level and impulsivity level. The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up
Time frame: Baseline, 2-month
The Metacognition Index (MI) of the BRIEF reflects a child's ability to self-manage and monitor tasks cognitively. The subscale is composed of the Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor scales of the BRIEF. It uses a Likert-type response format ranging from 1 to 3, where 1 is never, 2 is sometimes, and 3 is often. The MI subscale includes 40-items with score ranges between 0 to 120. Higher values represent worse outcome and greater difficulties with executive functions. High scores indicate executive deficit.

3 secondary outcomes

Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up
Time frame: 2-month
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up
Time frame: Baseline, 2-month
Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up
Time frame: Baseline, 2 months

Results and safety

Results posted to the registry on 7 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	32	24

Primary outcome: Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up

Time frame: Baseline, 2-month. Mean (Standard Error). Unit: score on a scale

Measure	Active n = 20
Baseline	30.30 (1.22)
End of study	22.85 (2.02)

Active: Mean Difference (Final Values): 7.45, p <0.001, t-test, 2 sided

Population analysed: Three participants did not complete the questionnaire.

Primary outcome: Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up

Time frame: Baseline, 2-month. Mean (Standard Error). Unit: score on a scale

Measure	Active n = 20
Baseline	18.00 (0.93)
End of study	14.10 (1.16)

Active: Mean Difference (Final Values): 3.9, p <0.001, t-test, 2 sided

Population analysed: Three participants did not complete the questionnaire.

Primary outcome: Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up

Time frame: Baseline, 2-month. Mean (Standard Error). Unit: score on a scale

Measure	Active n = 20
Baseline	12.30 (1.03)
End of study	8.75 (1.23)

Active: Mean Difference (Final Values): 3.55, p = 0.001, t-test, 2 sided

Population analysed: Three participants did not complete the questionnaire.

Primary outcome: Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up

Time frame: Baseline, 2-month. Mean (Standard Error). Unit: score on a scale

Measure	Active n = 19
Baseline	107.89 (2.11)
End of study	102.74 (2.94)

Active: Mean Difference (Final Values): 5.16, p = 0.032, t-test, 2 sided

Population analysed: Four participants did not complete the questionnaire.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected during the two-month intervention period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	0 of 24 (0%)	15 of 24 (62.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for ADHD

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Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zohar Elyoseph, PhD principal investigator

Max Stern Academic College of Emek Yezreel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VIZO Glasses in people with ADHD, run by VIZO Specs Ltd at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up (time frame: Baseline, 2-month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05835336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.