An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations

Qbtech AB

Status: Invitation-only

Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Healthy Volunteer; No History of ADHD

Treatments: Device: QbMobile

Study type: Observational

Funder types: Industry

Identifiers

NCT07220330

00082479 / QB24-01

Details and patient eligibility

About

The purpose of this study is to investigate QbMobile ability to collect and provide accurate and objective data which can be used to facilitate assessment and treatment procedures for ADHD in a clinical setting as well as remotely.

Full description

This study aims to evaluate the performance of QbMobile in children, adolescents, and adults from the normative population, those referred for an initial ADHD assessment, and individuals with an ADHD diagnosis who are not currently receiving ADHD treatment.

Participants will complete the 10-minute QbMobile test on their personal device during a scheduled clinical visit. They will then repeat the test remotely the following day at the same time as the previous test +/-3 hours.

For participants referred for an ADHD assessment or a has an ADHD diagnosis, QbMobile must be completed prior to initiating any ADHD treatment.

Enrollment: 700 estimated patients

Sex: All

Ages: 6 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provide written informed consent (including parent/legal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile;
• Aged > 6 years and < 60 years old;
• Have no documented or suspected current or lifetime diagnosis of ADHD or referred for an initial assessment for ADHD or have a diagnosis of ADHD but not currently receiving treatment;
• Meet DSM-5 or ICD-11 criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation) per sites standard clinical care evaluation;
• Qbtech Rating Scale total score of >24 at Visit 1;
• Have adequate sensory and physical ability to complete QbMobile;
• Possess or has access to an iPhone model that supports QbMobile.

Exclusion criteria

• Intellectual disability designated by IQ<75;
• Has used psychostimulant medication within the past 7 days prior to Visit 1;
• A current medical diagnosis that could significantly affect test performance (brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g., vascular dementia, Alzheimer disease, etc.);
• Other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
• Substance use (e.g., alcohol, drugs) that may affect performance on the day of the tests.

Trial design

700 participants in 1 patient group

This single cohort includes subjects with and without ADHD.

Description:

Eligible participants that do not have a documented or suspected current or lifetime diagnosis of ADHD will be recruited from the general population using different recruitment activities (letters, posted flyers, etc.). Eligible participants being referred for their initial assessment or have a diagnosis of ADHD but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.

Treatment:

Device: QbMobile