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

A Novel Device for the Management of ADHD

ADHD

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) .

VIZO Glasses

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

The ASRS is a self-report instrument that comprises eighteen items that correspond with the DSM-V-TR criteria for ADHD. The ASRS-Self is a subject-administered instrument and subjects rate 18 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). The total score goes from 0 up to 72. Higher scores mean more symptoms and higher ADHD's impairments.

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.

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. On the Conners CPT 3, d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination).

The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. The BRIEF-A is composed of 75 items and each item is rated by subjects using a 3-point Likert scale ranging from 1 ('Never') to 3 ('Often').

A Novel Device for the Management of ADHD

About this trial

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Placebo

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