NCT07478458 ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder
| NCT ID | NCT07478458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Giannina Gaslini |
| Condition | ADHD - Attention Deficit Disorder With Hyperactivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-11-10 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate a new driving simulator, called ADRIS 2.1, developed for adolescents aged 13-18 years with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder that can affect attention, self-control, and decision-making. These challenges may impact daily activities, including driving. The ADRIS simulator allows participants to "drive" in a virtual environment while their performance is monitored. The system measures driving errors (such as not stopping at red lights), head and body movements, and heart rate, helping researchers understand how ADHD may affect driving-related behavior. Participants in the study will include both adolescents with ADHD and typically developing adolescents. All participants will complete standardized cognitive and behavioral assessments and take part in at least one driving simulation session. Adolescents with ADHD will return for follow-up visits and a subgroup will participate in a 6-week training program using the simulator. The main goal of the study is to measure differences in driving performance and attention between adolescents with and without ADHD. The study will also explore whether the simulator can detect improvements over time and in response to clinical treatment or simulator-based training. The results may help inform future clinical evaluations and support tools for adolescents with ADHD, with the potential to improve safety and quality of life.
Eligibility Criteria
Inclusion Criteria for ADHD subjects: * Age range 13-18 years (up to the age of nineteen) * Diagnosis of ADHD (hyperactive, inattentive and combined subtype) * Consent to participate in the study by the participant or, in the case of a minor, by their parent(s)/guardian(s). Inclusion Criteria for Control Group subjects: * Age- and sex-matched neurotypical adolescents * No diagnosis of ADHD or other neurodevelopmental disorders * Informed consent obtained from the participant if of legal age or from the legal guardian and assent from the minor Exclusion Criteria: * Visual deficits not corrected/correctable with the normal use of lenses. * Motor deficits clinically detected and/or previously diagnosed and that could compromise the use of the simulator (e.g. neurological diseases, psychiatric diseases, etc.). * Categorical diagnoses according to DSM-5 criteria such as Psychosis, Mood Disorders, Autism Spectrum Disorders, Intellectual Disabilities, Borderline Intellectual Functioning, Anxiety Disorders. * Patients with other conditions that could affect driving ability. * Denial / withddrawal of consent to the protocol
Contact & Investigator
Lino Nobili, MD PhD
PRINCIPAL INVESTIGATOR
IRCCS Istituto Giannina Gaslini
Frequently Asked Questions
Who can join the NCT07478458 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying ADHD - Attention Deficit Disorder With Hyperactivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07478458 currently recruiting?
Yes, NCT07478458 is actively recruiting participants. Contact the research team at linonobili@gaslini.org for enrollment information.
Where is the NCT07478458 trial being conducted?
This trial is being conducted at Genoa, Italy, Pisa, Italy.
Who is sponsoring the NCT07478458 clinical trial?
NCT07478458 is sponsored by Istituto Giannina Gaslini. The principal investigator is Lino Nobili, MD PhD at IRCCS Istituto Giannina Gaslini. The trial plans to enroll 120 participants.