Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 179 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Apollo Neuro device
Wearing of activated Apollo Neuro device for at least three hours/day for 30 of 35 consecutive days by Autistic children with SIB and sensory over and/or under responsivity.
干预措施: Apollo Neuro device (Device)