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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Establishment of Normative Statistics for QbMobile Performance [Срок оценки: 1 QbMobile test at the clinic visit (Day 1)]

Вторичные конечные точки (1)

• Exploratory Analysis of Additional Domain Parameters [Срок оценки: 1 QbMobile test at the clinic visit (Day 1)]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07330960 · 00091260 QB25-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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