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Autism Spectrum DisorderASDWNCT07504224

ASD Wearables Feasibility Study

A study testing 14-Day Device Monitoring in people with Autism Spectrum Disorder and Wearable Devices, run by Rady Pediatric Genomics & Systems Medicine Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Autism Spectrum Disorder, Wearable Devices
What is being tested?
14-Day Device Monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Jul 2024to 6 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rady Children's Hospital, San Diego

    San Diego, California, 92123

Other trials in United States

About this study

Official title: 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:

Read more
  • 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
Read the 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
Being tested
14-Day Device Monitoring
Keywords
autism spectrum disorder, adolescents, feasibility, wearable, device, form factor, tolerability, comparison
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 14-Day Device MonitoringDevice

    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 groups in NCT07504224
Study groupRoleWhat they receive
Wristband DeviceExperimentalAdolescents 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.
Receives: Device: 14-Day Device Monitoring
Headband DeviceExperimentalAdolescents 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.
Receives: Device: 14-Day Device Monitoring
Adhesive Patch DeviceExperimentalAdolescents 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.
Receives: Device: 14-Day Device Monitoring
Ring DeviceExperimentalAdolescents 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.
Receives: Device: 14-Day Device Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Wear Adherence (Data Completeness)

    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.

    Measured: 2 weeks

Secondary outcomes (3)

  1. Device Wear Adherence (Complete Expected Periods)

    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".

    Measured: 2 weeks

  2. Device Comfort

    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.

    Measured: 2 weeks

  3. Device Usability

    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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start15 Jul 2024
  3. Primary completion18 Dec 2025
  4. Study completion6 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants were assigned to one of four wearable device groups using a prespecified, non-random alternating assignment based on sequence of enrollment. Device assignment alternated across the four device types such that Participant 1 received Device 1, Participant 2 received Device 2, Participant 3 received Device 3, Participant 4 received Device 4, and the sequence repeated until 10 participants were assigned to each device group (N = 40 total).
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07504224
Sponsor's protocol ID
804905
Acronym
ASDW
Status last verified
Mar 2026
First submitted
6 Mar 2026
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect private medical information.

Publications

  • Wilson RB, Vangala S, Elashoff D, Safari T, Smith BA. Using Wearable Sensor Technology to Measure Motion Complexity in Infants at High Familial Risk for Autism Spectrum Disorder. Sensors (Basel). 2021 Jan 17;21(2):616. doi: 10.3390/s21020616.

    PubMed 33477359

  • Taj-Eldin M, Ryan C, O'Flynn B, Galvin P. A Review of Wearable Solutions for Physiological and Emotional Monitoring for Use by People with Autism Spectrum Disorder and Their Caregivers. Sensors (Basel). 2018 Dec 4;18(12):4271. doi: 10.3390/s18124271.

    PubMed 30518133

  • Hachisu T, Pan Y, Matsuda S, Bourreau B, Suzuki K. FaceLooks: A Smart Headband for Signaling Face-to-Face Behavior. Sensors (Basel). 2018 Jun 28;18(7):2066. doi: 10.3390/s18072066.

    PubMed 29958435

  • Goodwin MS, Mazefsky CA, Ioannidis S, Erdogmus D, Siegel M. Predicting aggression to others in youth with autism using a wearable biosensor. Autism Res. 2019 Aug;12(8):1286-1296. doi: 10.1002/aur.2151. Epub 2019 Jun 21.

    PubMed 31225952

  • Black MH, Milbourn B, Chen NTM, McGarry S, Wali F, Ho ASV, Lee M, Bolte S, Falkmer T, Girdler S. The use of wearable technology to measure and support abilities, disabilities and functional skills in autistic youth: a scoping review. Scand J Child Adolesc Psychiatr Psychol. 2020 Jul 2;8:48-69. doi: 10.21307/sjcapp-2020-006. eCollection 2020.

    PubMed 33520778

  • Billeci L, Tonacci A, Narzisi A, Manigrasso Z, Varanini M, Fulceri F, Lattarulo C, Calderoni S, Muratori F. Heart Rate Variability During a Joint Attention Task in Toddlers With Autism Spectrum Disorders. Front Physiol. 2018 May 1;9:467. doi: 10.3389/fphys.2018.00467. eCollection 2018.

    PubMed 29765335

Questions about this trial

What is this clinical trial studying?

A study testing 14-Day Device Monitoring in people with Autism Spectrum Disorder and Wearable Devices, run by Rady Pediatric Genomics & Systems Medicine Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Wear Adherence (Data Completeness) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07504224, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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