ADHDNCT05777785
A Novel Device for the Management of ADHD
A study testing VIZO Glasses in people with ADHD, run by VIZO Specs Ltd at 1 site in Israel.
Trial summary
This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses. Read more about this study
- Who is it for?
- Ages 18 to 40 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
- 108 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2022to 26 Mar 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
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 Adults
This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.
Read the detailed 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) .
- Conditions
- ADHD
- Being tested
- VIZO Glasses
- Keywords
- ADHD, Peripheral Retinal Stimulation, non-pharmacological
- 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 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.
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.
Measured: 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.
Measured: Baseline, 2 months
Secondary outcomes (3)
Clinical Global Impression-Improvement (CGI-I) - Rate 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 months
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
Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up
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 subscale includes 40-items with score ranges between 40 to 120. Higher values represent worse outcome and greater difficulties with executive functions.
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.
- First posted21 Mar 2023
- Study start1 Apr 2022
- Primary completion1 Mar 2023
- Study completion26 Mar 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIZO Specs Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zohar Elyoseph, PhD, Principal investigator, Max Stern Academic College of Emek Yezreel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777785
- Sponsor's protocol ID
- VIZO_003
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2023
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37928920
Study at a glance
From the registry record, last updated by the sponsor on 25 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 Adults
- ClinicalTrials.gov ID
- NCT05777785
- Acronym / sponsor ID
- VIZO_003
- Conditions
- ADHD
- Keywords
- ADHD, Peripheral Retinal Stimulation, non-pharmacological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- VIZO Specs LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Posted 25 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-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.
Detailed 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) .
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
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
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)
- 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
Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up
Time frame: 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.
Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up
Time frame: 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.
3 secondary outcomes
Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up
Time frame: 2 months
Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up
Time frame: Baseline, 2 months
Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up
Time frame: Baseline, 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37928920Richter 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.
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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 4 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 25 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 25 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?
Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up (time frame: Baseline, 2 months). The study lists 2 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 NCT05777785, which also lists 1 linked publication.
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 25 Mar 2025.