Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior
Virginia Commonwealth University
Summary
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.
Description
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.
Eligibility
- Age range
- 6–14 years
- Sex
- All
- Healthy volunteers
- No
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) * signific…
Interventions
- DeviceApollo 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.
Location
- Virginia Commonwealth UniersityRichmond, Virginia