Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

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.

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.

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