Augmenting Existing Normative Data for QbMobile in Healthy Children Aged 6-11 Years

NCT07330960 | Not Yet Recruiting

• 1 other identifier: 00091260 QB25-02
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to strengthen the normative QbMobile data for children and adolescents age 6-11 years to allow for a more robust and accurate representation when comparing a patient's QbMobile performance with the appropriate normative reference group.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Establishment of Normative Statistics for QbMobile Performance

  Normative data will be analyzed to generate Standard Deviation (SD) scores and Total Scores for four domains: activity, impulsivity, inattention, and movement patterns. QbMobile SD-scores are standardized metrics derived from the main parameters (attention, impulsivity, activity and movement). These scores are calculated using and age and sex at birth adjusted normative dataset. The QbMobile also produces a Total Score number ranging from 0 to 100, where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms. These scores will enable individual test performance to be expressed relative to normative benchmarks.

  1 QbMobile test at the clinic visit (Day 1)

Secondary Outcomes (1)

• Exploratory Analysis of Additional Domain Parameters

  1 QbMobile test at the clinic visit (Day 1)

Study Arms (1)

Healthy Volunteers

Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)

Interventions

Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) DEVICE

Participants will complete a non-invasive, 10-minute digital tests using the QbMobile Investigational Device. The test objectively measure cognitive performance and activity levels.

Healthy Volunteers

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

The study population consists of a community-based sample of healthy children aged 6 to 11 years with no history of ADHD. Participants are primarily identified through local schools, community youth organizations, and general practitioners, with additional participants identified through the general patient databases of participating clinical sites.

You may qualify if:

• Provide informed consent from parent/legal guardians and assent for all study participants for the QbMobile study;
• Aged \> 6 years and \< 11 years old;
• Have no documented or suspected current or lifetime diagnosis of ADHD;
• Have adequate sensory and physical ability to complete QbMobile;

You may not qualify if:

• Intellectual disability designated by IQ\<75;
• Has a concurrent medical diagnosis that could significantly affect test performance such as brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g. vascular dementia, Alzheimer disease), unmanaged psychiatric illness;
• Has 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

Central Study Contacts

Robert Nolen

CONTACT

18325370300; robert.nolen@qbtech.com

Ragini Sanyal

CONTACT

ragini.sanyal@qbtech.com

Study Design

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

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share