ASD Wearables Feasibility Study

Conditions

• Autism Spectrum Disorder
• Wearable Devices

Eligibility Criteria

Sex

ALL

Age

13 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• 14-Day Device Monitoring — DEVICE
  Adolescents will receive a wearable device, of the form factor device group (wristband, headband, adhesive patch, ring) they were sequentially assigned to at enrollment, to wear for a consecutive period of 14 days. Participants will be asked to go about their daily life normally with awareness of the wearable device requirements and limits specific to their assigned study arm. Researchers will remotely monitor the data collected by these wearable devices and intervene during this two-week trial if no data is being obtained.

Study Details

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

Key Dates

Start date

Jul 15, 2024

Status verified

Mar 2026

Primary completion

Dec 18, 2025

Completion

Jan 6, 2026

Study Design

Enrollment

40 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Device Wear Adherence (Data Completeness) [ Time Frame: 2 weeks ]

Locations (1)

Find similar trials in San Diego, CA

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