ASD Wearables Feasibility Study

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

NCT Number	NCT07504224
Lead Sponsor	Rady Pediatric Genomics & Systems Medicine Institute Collaborators: Rady Children's Hospital, San Diego, University of California, San Diego
Conditions	Autism Spectrum Disorder, Wearable Devices
Enrollment	40 participants
Start Date	2024-07-15
Primary Completion	2025-12-18 (estimated)
Study Completion	2026-01-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-06