Can a gentle vibrating wearable reduce Self-Harm in autistic kids?
NCT ID NCT07648420
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This study will test whether a wearable device called Apollo Neuro is practical and acceptable for autistic children aged 6 to 14 who hurt themselves. The device delivers low-intensity vibrations through the skin. For about a month, 18 children will wear it at least 3 hours a day while caregivers track how often they use it and report on their child's behavior. This is a small, early-stage study focused on feasibility, not on proving the device works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apollo Neuro wearable device (vibrotactile sensory device)
- What this could lead to
- If this device is found to be easy to use and acceptable, it could pave the way for larger studies testing whether it helps reduce self-injurious behavior in autistic children.
- What could go wrong
- This is a very small, early feasibility study with only 18 participants and no control group. It is not designed to prove the device works, and results may not apply to all children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 years to 179 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virginia Commonwealth Uniersity
Richmond, Virginia, 23298, United States
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