Using Apollo Neuro in Autistic Children With Self-Injurious Behavior (NCT07648420) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Using Apollo Neuro in Autistic Children With Self-Injurious Behavior
United States18 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
6 Years – 179 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.