NCT07504224Completed
ASD Wearables Feasibility Study
Feasibility of Wearable Devices as a Source of Data to Support HealthAI in Autism Spectrum Disorder Populations
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 6 Mar 2026
- Start date
- 15 Jul 2024
- Primary completion date
- 18 Dec 2025
- Lead sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
- Diseases
- Autism
- NCT number
- NCT07504224
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 15 Jul 2024 to the primary completion date, 18 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.