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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)

Detailed Description

Participants will be recruited and referred from selected clinics' general population databases, local schools, youth centers and organizations, as well as other general practitioners within the surrounding area.

Participants will be pre-screened via an online questionnaire completed by their parent/legal guardian designed to capture diagnostic history and general demographic information. Access to the questionnaire will be initiated by scanning a QR code on the study flyer that will be visibly posted at locations listed above.

Parents or legal guardians will be asked to provide a reliable phone number within the pre-screening questionnaire, which will be used by the research team to follow up and verify the information submitted in the questionnaire. Once eligibility is confirmed through both the questionnaire and phone verification, participants will be scheduled for enrollment in the study.

On the scheduled study day, participants will complete a 10-minute QbMobile test.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Robert Nolen; Phone Number: 18325370300; Email: robert.nolen@qbtech.com
• Study Contact Backup: Name: Ragini Sanyal; Email: ragini.sanyal@qbtech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers	Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Analysis of Additional Domain Parameters	Exploratory analyses will be conducted on raw QbMobile data collected at Day 1 to identify potential additional parameters that may serve as indices of activity, attention, impulsivity, and movement from the QbMobile Standard Deviation (SD) Scores and Total Scores. 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 parameters will be evaluated for their potential association with ADHD symptomatology.	1 QbMobile test at the clinic visit (Day 1)

Collaborators and Investigators

• Sponsor: Qbtech AB

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer
• Other Study ID Numbers: 00091260 QB25-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the nature of the research, limited access to supporting data may be granted upon reasonable request under confidentiality agreements from the corresponding sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No