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OpenTrials
Enrolling by Invitation

NCT Number: NCT07217977

An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD

The current study will investigate if QbMobile can be used to improve the accuracy and objective identification of reduced ADHD symptoms in tests scores once treatment has been initiated.

Enrolling by Invitation

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Key information

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Focus-MD, Mobile, Alabama, United States

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About this study

This 4-week study will evaluate QbMobile's performance in monitoring ADHD treatment response. 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 before beginning their ADHD medication treatment. At week 2 and week 4, participants will take QbMobile remotely at least 1 hour after taking their ADHD medication and no longer than 4 hours post dose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Referred for an ADHD assessment or has a diagnosis of ADHD but not currently receiving any type of stimulant or nonstimulant medication treatment;
  • Meets 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.

Exclusion criteria

  • Intellectual disability designated by IQ<75);
  • Has used psychostimulant medication within 7 days prior to Visit 1;
  • A concurrent 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 test.

Treatment and study plan

observational study

Other

observational study

Primary outcomes

  1. Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4

    Time frame: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)

    Change in the QbMobile Total Score from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment related responses over time. The QbMobile 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. This score is automatically generated in a standard report immediately upon completion of QbMobile.

Secondary outcomes

  1. Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4

    Time frame: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)

    Change in the QbMobile SD-scores (Standard Deviation scores) from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment-related effects over time. 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 SD-scores are produced in the QbMobile report generated after completion of QbMobile.

Sponsors and collaborators

Lead sponsor

Qbtech AB

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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