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临床试验

ASD Wearables Feasibility Study

NCT:NCT07504224 · COMPLETED

NCT编号NCT07504224
状态COMPLETED
开始日期2024-07-15
完成时间2026-01-06

简要摘要

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

官方来源

在 ClinicalTrials.gov 上查看 →

数据来自 ClinicalTrials.gov API。有关最新状态,请参阅官方记录。

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