No History of ADHDNCT07220330

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

An observational study of No History of ADHD and Attention Deficit Hyperactivity Disorder (ADHD), run by Qbtech AB at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 6 to 60 yearsHealthy volunteers can take part
Conditions the study is for: No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer
What is being tested?: QbMobile
Type of treatment: Medical device
How many people: 700 participants
Where: 3 sitesUnited States
Study dates: 15 Jan 2025to Oct 2026
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: Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.

Who may be able to join

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.

Who cannot join

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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites

Bokhari Medical Consortium
Largo, Florida, 33770
Nona Pediatric Center
Orlando, Florida, 32832
Prodigy Psychiatric Group
San Jose, California, 95138

Other trials in United States

About this study

Read the detailed 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.

Conditions: No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer
Being tested: QbMobile
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QbMobileDevice
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.

Study groups in NCT07220330
Study group	Role	What they receive
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. Receives: Device: QbMobile

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10-minute testing period

Secondary outcomes (3)

QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups
QbMobile Total score (0-100 where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms) will be compared across participants assessed for ADHD, diagnosed but untreated, and normative participants to evaluate differentiation in ADHD symptom likelihood. This score is automatically generated in the QbMobile report upon test completion.
Measured: 10 minute testing period
Comparison of QbMobile SD-Scores Across Testing Environments
SD-scores for attention, impulsivity, activity, and movement patterns will be compared between in-clinic and remote QbMobile tests to assess consistency and reliability.
Measured: 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
Exploratory analyses will be conducted on raw QbMobile data collected at Visit 1 and Visit 2 to identify potential additional parameters that may serve as indices of activity, attention, impulsivity, and movement. These parameters will be evaluated for their potential association with ADHD symptomatology.
Measured: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 2025Oct 2026

First posted23 Oct 2025
Study start15 Jan 2025
Primary completionOct 2026 (estimated)
Study completionOct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for No History of ADHDStudies 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: Cohort
Time perspective: Prospective
Enrolment: 700 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07220330
Sponsor's protocol ID: 00082479 / QB24-01
Status last verified: May 2026
First submitted: 15 Oct 2025
Last updated: 6 May 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations
ClinicalTrials.gov ID: NCT07220330
Acronym / sponsor ID: 00082479 / QB24-01
Conditions: No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 700 participants (estimated)
Lead sponsor: Qbtech ABIndustry (pharma, biotech, devices)
Study start: 15 Jan 2025 (actual)
Primary completion: Oct 2026 (estimated)
Study completion: Oct 2026 (estimated)
First posted: 23 Oct 2025 (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.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
This single cohort includes subjects with and without ADHD.	–	Device: QbMobileEligible 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.

Who may qualify

Ages: 6 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (5 listed)

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.

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
QbMobileQbMobile 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.	Device	This single cohort includes subjects with and without ADHD.

Primary outcome

Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns.
Time frame: 10-minute testing period
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.

3 secondary outcomes

QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups
Time frame: 10 minute testing period
Comparison of QbMobile SD-Scores Across Testing Environments
Time frame: 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
Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).

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 6 May 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.

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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of No History of ADHD and Attention Deficit Hyperactivity Disorder (ADHD), run by Qbtech AB at 3 sites in United States.

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 7 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns. (time frame: 10-minute testing period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07220330.

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 6 May 2026.