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Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare

Schweitzer Engineering Laboratories · with Palouse Pediatrics, Pullman Regional Hospital · NCT07903675

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–5 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
330
US sites recruiting
4
Study start
October 23, 2026
Record last updated
October 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Autism spectrum disorder (ASD) is a developmental condition that can affect communication, social interaction, and behavior. Identifying ASD early helps children and families access support services sooner. Pupillometry is a way of measuring the nervous system and brain function by recording the pupil response to light. It is a non-invasive technology that may support screening practices by providing health care providers with an objective physical measure to bolster behavioral screening tools used to identify children with ASD .

This study is evaluating how well the APS Detect™ handheld pupillometer works to help screen for ASD in children 2 to 4 years of age during routine pediatric healthcare visits. This investigational device measures the child's pupil response to light and uses these measurements to estimate the likelihood of ASD.

Researchers will compare screening results using the APS Detect with the results of reference standard clinical assessments used to determine whether a child has autism. The study will assess how accurately the device identifies children with autism compared to children with typical development based on the Autism Pupil Screen (APS) score.

The study will also evaluate whether the device provides the same results when used by different healthcare professionals. Information collected during this study will be used to evaluate device performance, safety, and suitability for use in pediatric healthcare settings and may support future review by the U.S. Food and Drug Administration (FDA).

Being studied: Autism Pupil Screen (APS) Detect PLR Assessment #1; Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F); Social Responsiveness Scale, Second Edition (SRS-2); Autism Diagnostic Observation Schedule, Second Edition (ADOS-2); Mullen Scales of Early Learning (MSEL); Adaptive Behavior Assessment System, Third Edition (ABAS-3); Autism Pupil Screen (APS) Detect PLR Assessment #2; Autism Pupil Screen (APS) Detect Assessment #3; Well-child check

Conditions: Autism Spectrum Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Children between 24 months and 60 months of age

Exclusion Criteria

Children with a prior diagnosis of ASD Children experiencing a seizure within the past 6 months prior to the first day of testing Children that have experienced head trauma Children that have hearing loss or vision loss corrected or uncorrected that impacts their daily life Children that had any known exposure to alcohol, drugs, prescription medications, or environmental toxins before or after birth

Recruiting US locations

  • SEL Health Clinic - Lewiston

    Lewiston, ID 83501

    Site contact: Keith Gautreaux · (509)338-3800 · keith_gautreaux@selinc.com

  • Palouse Pediatrics

    Moscow, ID 83843

    Site contact: Kathryn Hryniewicz, MD · (208)882-2247 · kathryn.hryniewicz@pullmanregional.org

  • Palouse Pediatrics

    Pullman, WA 99163

    Site contact: Kathryn Hryniewicz, MD · (509)332-2605 · kathryn.hryniewicz@pullmanregional.org

  • SEL Health Clinic - Pullman

    Pullman, WA 99163

    Site contact: Keith Gautreaux, MD · (509)338-3800 · keith_gautreaux@selinc.com

Study contacts (from the official record)

  • Georgina Lynch, PhD · 509-334-8800 · clinicaltrials@selinc.com
  • Alyssa Knight · 509-334-8800 · clinicaltrials@selinc.com
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Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer… (NCT07903675) | Bored Studies