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

NCT07220330 | Enrolling By Invitation

• 1 other identifier: 00082479 / QB24-01
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns.

  QbMobile generates standardized scores (SD-scores) for attention, impulsivity, activity, and movement patterns using age and sex at birth adjusted norms. These scores provide objective data collected during the 10-minute test session and are automatically included in a standardized report generated immediately upon test completion. This supports evaluation of test validity for ADHD-related symptom measurement.

  10-minute testing period

Secondary Outcomes (3)

• QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups

  10 minute testing period

• Comparison of QbMobile SD-Scores Across Testing Environments

  Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)

• Exploratory Identification of Novel QbMobile Derived Parameters Reflecting Activity, Movement, Attention, and Impulsivity

  QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).

Study Arms (1)

This single cohort includes subjects with and without ADHD.

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.

Device: QbMobile

Interventions

QbMobile DEVICE

QbMobile is a software application that can be installed on a smartphone device used to measure activity, attention, impulsivity, and movement patterns in participants over a two-day period.

This single cohort includes subjects with and without ADHD.

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qbtech AB: lead

Study Sites (3)

Prodigy Psychiatric Group

San Jose, California, 95138, United States

Location

Bokhari Medical Consortium

Largo, Florida, 33770, United States

Location

Nona Pediatric Center

Orlando, Florida, 32832, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 23, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)