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Not yet recruiting NCT07648420

Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

No phase Interventional Self-Injurious Behavior Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apollo Neuro device.
Who it may be relevant to
Registry conditions: Self-Injurious Behavior, Autism Spectrum Disorder. Basic parameters: 6 years — 179 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

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.

Primary outcome measures

  • Adherence to wearing the Apollo Neuro Wearable [Time frame: 30-35 days]
  • Acceptability of Intervention Measure (AIM) [Time frame: 30-35 days]
  • Feasibility of Intervention Measure (FIM) [Time frame: 30-35 days]
  • The Repetitive Behavior Scale-Revised (RBS-R) [Time frame: 30-35 days]
  • Change in intensity of self-injurious behavior [Time frame: 30-35 days]
  • Changes in caregiver-reported SIB intensity [Time frame: 30-35 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Virginia Commonwealth Uniersity — Richmond

Identifiers

NCT: NCT07648420 · HM300001048

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗