Home › Autism Spectrum Disorder › NCT07903675
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Who can join
24 Months – 60 Months · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
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).
What is being tested
- Autism Pupil Screen (APS) Detect PLR Assessment #1 (device)
- Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F) (other)
- Social Responsiveness Scale, Second Edition (SRS-2) (other)
- Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) (diagnostic test)
- Mullen Scales of Early Learning (MSEL) (other)
- Adaptive Behavior Assessment System, Third Edition (ABAS-3) (other)
Sponsor: Schweitzer Engineering Laboratories · Participants: 330 · Started: Oct 23, 2026
Contact the study team
- Georgina Lynch, PhD · Phone: 509-334-8800
- Alyssa Knight · Phone: 509-334-8800
Official record on ClinicalTrials.gov — NCT07903675
Locations in the U.S.
| Idaho | SEL Health Clinic - Lewiston, Lewiston Palouse Pediatrics, Moscow |
| Washington | Palouse Pediatrics, Pullman SEL Health Clinic - Pullman, Pullman |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.