NCT05874466Recruiting
SenseToKnow Autism Screening Device Validation Study
SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 12 May 2023
- Start date
- 7 Jul 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- Duke University
- Diseases
- Autism
- NCT number
- NCT05874466
What you commit to
- Study type: Observational
- Planned participants: 350
- From 7 Jul 2023 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving therapies that affect vision
Other illness
- Severe motor impairment that precludes study measure completion
- Known genetic disorders
- Severe hearing or visual impairment as determined on physical examination according to parent report
- Acute illnesses likely to prevent successful or valid data collection
- Uncontrolled epilepsy or seizure disorder
- History or presence of a clinically significant medical disease, or a mental state that could confound the study or be detrimental to the subject as determined by the investigator
- Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
Other
- Parent/legal guardian and/or investigator believes that the child will be unable/unwilling to sit in the parent's lap to watch the app videos
- Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
- Participants who are otherwise judged as unable to comply with the protocol by the investigator
- Any other factor that the investigator feels would make the study measures invalid
Who the study is looking for
- Duke Health pediatric patient at enrollment
- 16-\<37 months of age at enrollment
- Parent/legal guardian speaks English or Spanish
- Parent/legal guardian understands and voluntarily provides informed consent
Age in the registry: 16 months to 36 months · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.