ASD Wearables Feasibility Study (ASDW)

March 31, 2026 updated by: Aaron Besterman, Rady Pediatric Genomics & Systems Medicine Institute

Feasibility of Wearable Devices as a Source of Data to Support HealthAI in Autism Spectrum Disorder Populations

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

  • Virtual e-consent for adolescent and caregiver assent and consent
  • Virtual semi-structured interview #1
  • Device assignment

Study Visit #2: Day 2 (60 minutes)

  • In person participant assessment
  • NIH toolbox V2 Cognitive & Emotional Assessment Batteries
  • In person caregiver assessments:
  • Short Sensory Profile-2 (SSP-2)
  • Social Responsiveness Scale (SRS-2)
  • Child Behavior Checklist (CBCL)
  • Medical history questionnaire
  • Receive allocated device assignment
  • Priming: Social Story - Participants will be introduced to their wearable device via a social story to prepare them to better understand and manage their involvement in the study.
  • 1st $25 compensation installment

Days 3-16

  • Adolescent will wear the wearable device for 2 weeks
  • During the two weeks, usage will be tracked by a researcher who may contact participants to intervene if no data are being collected

Study Visit #3: Day 17

  • Virtual semi-structured interview #2
  • Caregiver assessments
  • System Usability Scale (SUS)
  • Comfort Rating Scale (CRS)

Study Visit #4: Day 18

  • Return device to study
  • 2nd $25 compensation installment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Rady Children's Hospital, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of acute psychiatric symptoms, such as:

    1. Suicidal ideation (SI)
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 14-Day Device Monitoring
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.
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.
Device: 14-Day Device Monitoring
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.
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.
Device: 14-Day Device Monitoring
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.
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.
Device: 14-Day Device Monitoring
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Wear Adherence (Data Completeness)
Time Frame: 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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Wear Adherence (Complete Expected Periods)
Time Frame: 2 weeks

To account for differences in expected period of device wear (night-only vs continuous) Complete Expected Periods is effectively a discretized version of Completeness that segments time into Day and Night periods.

Day Period: A 14-hour window from 08:00 to 22:00. Night Period: A 10-hour window from 22:00 to 08:00. A given period was considered "complete" if the number of minutes that contained valid data exceeded a common threshold for data inclusion. This corresponded to 600 minutes (10 hours) of data for the day period, and 360 minutes (6 hours) for the night period. For the headband and ring, only night periods were expected, so 6 hours of data over a 24-hour period (12pm-12pm) was considered "complete".
2 weeks
Device Comfort
Time Frame: 2 weeks
The Comfort Rating Scale (CRS; Knight et al., 2002) will be used to measure adolescent and caregiver perceptions of the comfortability of the assigned wearable device. Scores are aggregated to identify specific aspects of the device that may cause discomfort, facilitating targeted design improvements for wearable systems.
2 weeks
Device Usability
Time Frame: 2 weeks
The System Usability Scale (SUS; Brooke, 1996) will be used to measure adolescent and caregiver perceptions of the usability of each device and corresponding data capturing system. To calculate the SUS score, individual item scores are transformed and summed to produce a single value ranging from 0 to 100. This score represents a composite measure of the overall usability of the system being studied.
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Responses: Adolescent and Caregiver Feedback
Time Frame: 2 weeks
Qualitative feedback from post-device interviews with participants and caregivers will be collected to explore experiences with wearable device use, including perceptions of overall benefits, challenges, and mental health impact associated with wearing the device for two-weeks. Responses will be analyzed descriptively to identify common themes related to feasibility of wearable device use in adolescents with ASD.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rady Pediatric Genomics & Systems Medicine Institute

Collaborators

University of California, San Diego
Rady Children's Hospital, San Diego

Investigators

  • Principal Investigator: Aaron Besterman, M.D., Rady Children's Institute for Genomic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Actual)

December 18, 2025

Study Completion (Actual)

January 6, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804905

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect private medical information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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