Background: Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, impulsivity, and impaired executive functioning. It typically begins in childhood and is often first diagnosed at school age due to learning and social behavioral difficulties. Therefore, ADHD treatment aims to directly enhance attention, reduce hyperactivity and impulsivity, and ultimately improve task performance and associated behavioral and relational issues. Objective of the Clinical Trial: To evaluate the safety of the investigational digital therapeutic device for the treatment of ADHD. To evaluate the efficacy of the investigational digital therapeutic device for the treatment of ADHD. Study Design \& Methodology: A total of 122 participants were enrolled (62 in the treatment group and 60 in the control group), with 114 participants included in the Full Analysis Set (FAS: 58 treatment, 56 control).
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Change from baseline in ADHD-RS (Investigator-Rated Scale) at end of treatment (FAS)
Timeframe: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.