NCT07648420Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- Dec 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Autism
- NCT number
- NCT07648420
What you commit to
- Study type: Interventional
- Planned participants: 18
- From Dec 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Known seizure disorder without physician clearance
Other
- Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days
- Unable to provide informed consent in English
Who the study is looking for
- 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
Age in the registry: 6 years to 179 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth Uniersity Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.