About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

implanted medical or neurological devices (e.g., pacemaker)

significant cardiac conditions or arrhythmias

history of syncope (fainting)

Known seizure disorder without physician clearance

Trial design

Design model

Single group

Treatments tested in this trial

Apollo Neuro device
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.

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: Apollo Neuro deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adherence to wearing the Apollo Neuro Wearable

Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions.

Time frame

30-35 days

2

Acceptability of Intervention Measure (AIM)

Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions.

Time frame

30-35 days

3

Feasibility of Intervention Measure (FIM)

Caregiver-reported feasibility of the intervention, as measured by the Feasibility of Intervention Measure (FIM), a validated 4-item instrument assessing the extent to which the intervention can be successfully implemented within the home setting. Each item is rated on a 5-point Likert scale ranging from 1(Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions.

Time frame

30-35 days

4

The Repetitive Behavior Scale-Revised (RBS-R)

Caregiver-reported behaviors, as measured by the Repetitive Behavior Scale-Revised (RBS-R), a validated 43-item questionnaire assessing the presence and severity of restricted and repetitive behaviors in individuals with autism spectrum disorder, including self-injurious behavior. The measure is completed by caregivers at baseline and post-intervention using a 4-point Likert scale. Scores will be summarized descriptively to characterize patterns over the study period.

Time frame

30-35 days

Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts