Feasibility of Wearable Devices as a Source of Data to Support HealthAI in Autism Spectrum Disorder Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Device Wear Adherence (Data Completeness)
研究概览
简要总结
The goal of this clinical study is to evaluate and compare the feasibility of wearable device use among pediatric participants with autism spectrum disorder (ASD) across four different wearable device form factors: a wristband, headband, adhesive patch, and finger ring. Rather than investigating health or clinical outcomes associated with wearable device use, the study focuses on comparative assessment of device types to determine which forms are most acceptable and practical for this population.
The study explores factors that may influence feasibility, including comfort, wearability, sustained use, and participant and caregiver engagement. The main questions the study aims to answer are:
- Were adolescents with ASD able to tolerate wearing the assigned device for the full two-week study period?
- Did adolescents with ASD and their caregivers consider the wearable device to be comfortable and usable?
- Were there any unanticipated factors that affected the feasibility of wearable device use among youth with ASD?
Researchers will compare data collected across device groups to determine (1) which form factor performed most effectively in real-world settings, and (2) which design characteristics are most important to consider when developing or selecting wearable devices intended for safe, acceptable, and sustained use in adolescent ASD populations.
Adolescent participants and their caregivers will:
- Be asked to complete four research visits (two in-person and two virtual video visits)
- Complete multiple questionnaires (caregivers), assessments (adolescents) and two semi-structured interviews
- Wear the assigned wearable device, as instructed, for a two-week trial: either a headband, wristband, adhesive patch, or finger ring
详细描述
Wearable devices are increasingly used to support clinical research and caregiver decision-making; however, individuals with autism spectrum disorder (ASD) may experience unique challenges related to wearable device use. Sensory sensitivities and responses to physical stimuli may affect the tolerability, comfort, and sustained use of wearable technologies in this population. As a result, understanding how adolescents with ASD interact with and perceive different wearable device designs is an important step in selecting and developing devices suitable for real-world use.
This clinical study is a comparative evaluation of wearable device use across four different device form factors-a wristband, headband, adhesive patch, and finger ring-under real-world conditions in adolescents with ASD. The study examines feasibility-related factors, including device tolerability, comfort, usability, and wearability over a two-week study period. Participants are assigned to a single device type, and data are collected to assess their experiences using the assigned wearable during daily activities.
Rather than focusing on physiological mechanisms or evaluating clinical or health outcomes, this study is designed to generate comparative information on how different wearable device designs are experienced by pediatric participants with ASD. Findings from this study are intended to inform future research, development, and selection of wearable technologies that are acceptable, practical, and suitable for use in adolescent ASD populations.
Event Overview:
Study Visit #1: Day 1 (90 min)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent and assent forms
- •Stated willingness to comply with all study procedures
- •Stated availability for the duration of the study
- •Parent provided diagnosis of autism spectrum disorder confirmed via formalized assessment
排除标准
- •Presence of acute psychiatric symptoms, such as:
- •Suicidal ideation (SI)
- •Homicidal ideation (HI) During the prescreening call, the researcher will ask the prospective adolescent participant, "Do you have thoughts of harming yourself or others?" and if yes, the researcher will contact the PI and contact 911 depending on acuity of situation.
研究组 & 干预措施
Wristband Device
Adolescents in this arm will wear receive a Fitbit Inspire 2 as a wristband form factor device for the 14-day wearable device trial. The wristband should be worn continuously but removed to charge during showers.
干预措施: 14-Day Device Monitoring (Device)
Headband Device
Adolescents in this arm will wear receive a Muse S Headband as a headband form factor device for the 14-day wearable device trial. The headband should be worn for sleep only and will need to be charged during the day.
干预措施: 14-Day Device Monitoring (Device)
Adhesive Patch Device
Adolescents in this arm will wear receive a Vivalink Multi Vital Monitor (VV350) ECG patch as an adhesive patch form factor device for the 14-day wearable device trial. The patch should be worn continuously and not removed for showers.
干预措施: 14-Day Device Monitoring (Device)
Ring Device
Adolescents in this arm will wear receive a Wellue O2 Ring as a ring form factor device for the 14-day wearable device trial. The ring should be worn for sleep only and will need to be charged during the day.
干预措施: 14-Day Device Monitoring (Device)
结局指标
主要结局
Device Wear Adherence (Data Completeness)
时间窗: 2 weeks
A device-specific data completeness score will be calculated for each participant as a measure of adherence to the device wear protocol. Completeness is defined as the percentage of expected wear time during which valid device data were successfully recorded. Expected daily wear duration was defined as 24 hours for the wristband and adhesive patch, and 8 hours for the headband and finger ring. For devices with an 8-hour expected wear period, days with 8 or more hours of valid data were considered 100% complete. Completeness scores will be summarized by device type to compare adherence across wearable form factors.
次要结局
- Device Wear Adherence (Complete Expected Periods)(2 weeks)
- Device Comfort(2 weeks)
- Device Usability(2 weeks)
研究者
Aaron Besterman
Clinical Investigator
Rady Pediatric Genomics & Systems Medicine Institute