SenseToKnow Autism Screening Device Validation Study

NCT05874466 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2026-03-06

No results posted yet for this study

Summary

This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the detection of autism spectrum disorder in children 16-36 months of age.

Conditions

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Duke University

    lead OTHER

Principal Investigators

  • Geraldine Dawson, PhD · Duke University

Eligibility

Min Age
16 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874466 on ClinicalTrials.gov