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Набор по приглашению NCT07220330

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

— Наблюдательное No History of ADHD Attention Deficit Hyperactivity Disorder (ADHD) Healthy Volunteer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: QbMobile.
Кому может быть актуально
Состояния в реестре: No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer. Базовые параметры: 6 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство QbMobile
    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.

Первичные конечные точки

  • Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns. [Срок оценки: 10-minute testing period]
Вторичные конечные точки (3)
  • QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups [Срок оценки: 10 minute testing period]
  • Comparison of QbMobile SD-Scores Across Testing Environments [Срок оценки: 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 [Срок оценки: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Prodigy Psychiatric Group — San Jose
  • Bokhari Medical Consortium — Largo
  • Nona Pediatric Center — Orlando

Идентификаторы

NCT: NCT07220330 · 00082479 / QB24-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗