Healthy VolunteerNCT07330960
Augmenting Existing Normative Data for QbMobile in Healthy Children Aged 6-11 Years
An observational study of Healthy Volunteer, run by Qbtech AB.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ragini Sanyal contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Not described Receives: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 QbMobile test at the clinic visit (Day 1)
Secondary outcomes (1)
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.
Measured: 1 QbMobile test at the clinic visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qbtech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330960
- Sponsor's protocol ID
- 00091260 QB25-02
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Existing Normative Data for QbMobile in Healthy Children Aged 6-11 Years.
- ClinicalTrials.gov ID
- NCT07330960
- Acronym / sponsor ID
- 00091260 QB25-02
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qbtech ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy Volunteers |
Primary outcome
Establishment of Normative Statistics for QbMobile Performance
Time frame: 1 QbMobile test at the clinic visit (Day 1)
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 secondary outcome
Exploratory Analysis of Additional Domain Parameters
Time frame: 1 QbMobile test at the clinic visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ragini Sanyal contact
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by Qbtech AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Nolen (18325370300, robert.nolen@qbtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of Normative Statistics for QbMobile Performance (time frame: 1 QbMobile test at the clinic visit (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.