A wearable vibrating device for autistic children who hurt themselves
Tests whether autistic children who injure themselves can use a wearable vibrating device.
Plain-language title generated from the registry record
Registry title: Using Apollo Neuro in Autistic Children With Self-Injurious Behavior
Key facts
- Where
- Richmond, United StatesSee the site
Where in United States
- Virginia Commonwealth UniersityRichmond, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Virginia Commonwealth University
- Trial code
- NCT07648420
- Record updated
- 17 August 2026
- Original description
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).Read full original descriptionShow less
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.
Inclusion: 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; 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: 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); Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures; Known seizure disorder without physician clearance; Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days; Unable to provide informed consent in English.