Using Apollo Neuro in Autistic Children With Self-Injurious Behavior
13 de agosto de 2026 actualizado por: Virginia Commonwealth University
Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior
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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
18
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Laura Lee Robins
- Número de teléfono: (757) 285-3486
- Correo electrónico: robinslp@vcu.edu
Ubicaciones de estudio
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth Uniersity
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Contacto:
- Laura Robins
- Número de teléfono: 757-541-8460
- Correo electrónico: robinslp@vcu.edu
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Investigador principal:
- Stacey Reynolds
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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:
• Unable to provide informed consent in English
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Apollo Neuro device
Wearing of activated Apollo Neuro device for at least three hours/day for 30 of 35 consecutive days by Autistic children with SIB and sensory over and/or under responsivity.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adherence to wearing the Apollo Neuro Wearable
Periodo de tiempo: 30-35 days
|
Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention.
Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
Responses will be summarized descriptively using mean scores and response distributions.
|
30-35 days
|
|
Acceptability of Intervention Measure (AIM)
Periodo de tiempo: 30-35 days
|
Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention.
Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
Responses will be summarized descriptively using mean scores and response distributions.
|
30-35 days
|
|
The Repetitive Behavior Scale-Revised (RBS-R)
Periodo de tiempo: 30-35 days
|
Caregiver-reported behaviors, as measured by the Repetitive Behavior Scale-Revised (RBS-R), a validated 43-item questionnaire assessing the presence and severity of restricted and repetitive behaviors in individuals with autism spectrum disorder, including self-injurious behavior.
The measure is completed by caregivers at baseline and post-intervention using a 4-point Likert scale.
Scores will be summarized descriptively to characterize patterns over the study period.
|
30-35 days
|
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Changes in caregiver-reported SIB intensity
Periodo de tiempo: 30-35 days
|
Daily caregiver-reported ratings of peak self-injurious behavior intensity, measured using a visual analog scale (VAS) recorded on a study-designed data collection form.
Caregivers will provide ratings each day throughout the intervention period.
Data will be summarized descriptively to characterize variability and patterns over time.
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30-35 days
|
|
Feasibility of Intervention Measure (FIM)
Periodo de tiempo: 30-35 days
|
Caregiver-reported feasibility of the intervention, as measured by the Feasibility of Intervention Measure (FIM), a validated 4-item instrument assessing the extent to which the intervention can be successfully implemented within the home setting.
Each item is rated on a 5-point Likert scale ranging from 1(Completely disagree) to 5 (Completely agree).
Responses will be summarized descriptively using mean scores and response distributions.
|
30-35 days
|
|
Change in intensity of self-injurious behavior
Periodo de tiempo: 30-35 days
|
Changes in the intensity of self-injurious behavior associated with the use of the Apollo Neuro wearable device will be measured by caregiver-reported tracking daily ratings of peak self-injurious behavior intensity on a study designed form tracking the participant adherence.
|
30-35 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Stacey Reynolds, Virginia Commonwealth University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de diciembre de 2026
Finalización primaria (Estimado)
1 de noviembre de 2027
Finalización del estudio (Estimado)
1 de noviembre de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HM300001048
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
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