Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT05874466
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2023-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SenseToKnow Autism Screening Device Validation Study
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the detection of autism spectrum disorder in children 16-36 months of age.
Detailed Description:
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the classification of autism spectrum disorder when administered by parents in a sample of patients 16-36 months of age. The trial design is a non-interventional cross-sectional study comparing the SenseToKnow app classification of autism spectrum disorder ("autism") versus non-autism with the patient's diagnostic status based on expert clinical diagnosis in a population of pediatric patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2P50HD093074 | NIH | None | https://reporter.nih.gov/quic… | View |