Augmenting Existing Normative Data for QbMobile in Healthy Children Aged 6-11 Years
ConditionHealthy Volunteer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-60
SponsorQbtech AB
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
DeviceParticipants will complete a non-invasive, 10-minute digital tests using the QbMobile Investigational Device. The test objectively measure cognitive performance and activity levels.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Healthy Volunteers1 intervention
Trial outcomes
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.
Time frame
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.
Time frame
1 QbMobile test at the clinic visit (Day 1)Locations
Source ClinicalTrials.gov
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