Набор скоро начнётся NCT07648420

Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

Без фазы С лечением Self-Injurious Behavior Autism Spectrum Disorder

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: Apollo Neuro device.
Кому может быть актуально: Состояния в реестре: Self-Injurious Behavior, Autism Spectrum Disorder. Базовые параметры: 6 лет — 179 мес. · 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior

Обзор

This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB). Participants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.

Подробное описание

who engage in self-injurious behavior (SIB). Participants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self-injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.

Вмешательства

Устройство Apollo Neuro device
Child participants will wear the activated device for a minimum of three hours per day on at least 30 of 35 consecutive days, consistent with the study protocol. The device is worn externally (e.g., wrist, ankle, or waist) and delivers low intensity vibrations through intact skin.

Первичные конечные точки

Adherence to wearing the Apollo Neuro Wearable [Срок оценки: 30-35 days]
Acceptability of Intervention Measure (AIM) [Срок оценки: 30-35 days]
Feasibility of Intervention Measure (FIM) [Срок оценки: 30-35 days]
The Repetitive Behavior Scale-Revised (RBS-R) [Срок оценки: 30-35 days]
Change in intensity of self-injurious behavior [Срок оценки: 30-35 days]
Changes in caregiver-reported SIB intensity [Срок оценки: 30-35 days]

Критерии участия

Inclusion Criteria for child:

Diagnosis of autism spectrum disorder (ASD), as reported by caregiver
Presence of self-injurious behavior, as reported by caregiver
Demonstrates sensory over and/or under- responsivity
Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment
Has a caregiver willing and able to provide consent and participate in study procedures

Exclusion Criteria for child:

Has medical condition that may increase risk with use of a wearable nibrotactile device, including:

implanted medical or neurological devices (e.g., pacemaker)
significant cardiac conditions or arrhythmias
history of syncope (fainting)
Known seizure disorder without physician clearance
Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days
Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures

Inclusion Criteria for Caregiver:

Parent or legal guardian of the enrolled child participant
Able to provide informed consent in English
Able and willing to support device use according to study protocol and complete study-related data collection
Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period

Exclusion Criteria for Caregiver: