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Trial · NCT07903675

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

NCT07903675, Recruiting, Schweitzer Engineering Laboratories

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare. Trials, record NCT07903675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903675

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
NCT number
NCT07903675
Status
Recruiting
Enrollment
330 participants, estimated
Lead sponsor
Schweitzer Engineering Laboratories
Conditions
Autism Spectrum Disorder
Interventions
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
First posted
2026-10-29
Last updated
2026-10-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySensitivity and Specificity of the APS Score to classify ASD diagnostic outcomeFrom enrollment to the end of all testing visits will be 14-30 days
This study will test the effectiveness of the APS Detect device results to accurately identify an atypical PLR score for children meeting the criteria for ASD. The study will also test the effectiveness of the APS Detect device results to accurately identify a typical PLR score for children who do not have ASD and have been identified as typically developing.
SecondaryPositive Predictive Values and Negative Predictive ValuesFrom enrollment to the end of all testing visits will be 14-30 days
These measures will assess the ability of the APS Detect score to predict the diagnostic outcome taking into consideration the prevalence of ASD, using prevalence rates reported by the Autism and Developmental Disabilities Monitoring Network. This measure will be taken at the end of the study for all child study participants enrolled. This helps determine how likely the device is to detect ASD in routine screening when compared to the general population.
OtherPrecision Study: Reliability and Reproducibility of the results of the APS DetectFrom enrollment to the end of all testing visits will be 14-30 days
Study participants selected for Arm B of this trial will be tested to evaluate how consistent the results are for the APS Detect. This part of the study will assess the percent of agreement between outcome measures obtained with the APS Detect over more than one administration of the pupil screening test administered by a different clinician for each test administration. A test of each individual pupil measurement that contributes to the APS Score will analyze the influence of those measurements on the final result obtained across study participants.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
25528080BACKGROUNDPubMed
25750705BACKGROUNDPubMed
28188684BACKGROUNDPubMed
29087041BACKGROUNDPubMed
29735992BACKGROUNDPubMed
30469373BACKGROUNDPubMed
31562252BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07903675

GET https://conductscience.org/api/trials/v1/NCT07903675/registered