Testing a handheld pupil device to help screen young children for autism
Tests a handheld pupil light device for screening autism in young children.
Plain-language title generated from the registry record
Registry title: Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Key facts
- Where
- Lewiston, Moscow, and Pullman, United StatesSee the 4 sites
Where in United States
- SEL Health Clinic - LewistonLewiston, United StatesTaking people
- Palouse PediatricsMoscow, United StatesTaking people
- Palouse PediatricsPullman, United StatesTaking people
- SEL Health Clinic - PullmanPullman, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Schweitzer Engineering Laboratories
- Trial code
- NCT07903675
- Record updated
- 29 October 2026
- Original description
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 .Read full original descriptionShow less
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
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).
Inclusion: Children between 24 months and 60 months of age.
Exclusion: 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.