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NOT YET RECRUITING
NCT07648420
NA

Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

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.

Official title: Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior

Key Details

Gender

All

Age Range

6 Years - 179 Months

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-07

Completion Date

2026-11

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

DEVICE

Apollo Neuro device

Child participants will wear the activated device for a minimum of three hours per day on at least 30 of 35 consecutive days, consistent with the study protocol. The device is worn externally (e.g., wrist, ankle, or waist) and delivers low intensity vibrations through intact skin.

Locations (1)

Virginia Commonwealth Uniersity

Richmond, Virginia, United States