Pupillometer screen to help identify autism in kids aged 2–4 during routine visits
Official title: Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Run by Schweitzer Engineering Laboratories · NCT07903675 · Data updated 2026-11-12
A handheld pupillometer test is being tried to see if it can help identify autism in young children during regular pediatric visits.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 24 Months to 60 Months |
| Sex | All |
| Enrollment | 330 (estimated) |
| Sponsor | Schweitzer Engineering Laboratories Industry-sponsored |
| Locations | 4 sites (Lewiston, Idaho and 3 other locations) |
| Status | Recruiting |
| Started | October 23, 2026 |
| Main results expected | April 16, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07903675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 24 to 60 months without a prior ASD diagnosis and without conditions that could confound testing.
✕Probably not a fit
Children with a prior ASD diagnosis or those with recent conditions or exposures that affect pupil response may not benefit from this screening approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study tests the APS Detect handheld pupillometer, which measures pupil responses to light, as a screening aid for autism in children aged 2 to 4. Participants will undergo PLR testing with the device and standard ASD evaluations to compare the device’s results with diagnostic outcomes. The study will report diagnostic performance metrics such as sensitivity, specificity, and predictive values, plus a sub-study on how consistently different clinicians obtain APS scores. Data from this real-world setting may support future regulatory submissions. The trial is sponsored by Schweitzer Engineering Laboratories with collaboration from local pediatric and academic partners.
Why it matters
Potential benefit: If successful, the APS Detect could provide clinicians with an objective, non-invasive screen to help identify ASD earlier in routine care.
How similar studies have gone: Previous studies of pupillometry for neurodevelopmental screening have shown variable results, making this evaluation important to determine real-world usefulness.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
SEL Health Clinic - Lewiston
Lewiston, Idaho, United States Recruiting -
Palouse Pediatrics
Moscow, Idaho, United States Recruiting -
Palouse Pediatrics
Pullman, Washington, United States Recruiting -
SEL Health Clinic - Pullman
Pullman, Washington, United States Recruiting
Study contacts
- Principal investigator: Georgina Lynch, PhD — Schweitzer Engineering Laboratories, Inc. Washington State University
- Study coordinator: Georgina Lynch, PhD
- Email: clinicaltrials@selinc.com
- Phone: 509-334-8800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.