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NCT05874466 · ClinicalTrials.gov registry record
SenseToKnow Autism Screening Device Validation Study
A clinical trial of Autism Spectrum Disorder and Autism, sponsored by Duke University.
- Recruiting
- Registry status
- 350
- Enrollment target
- 1
- Study location
NCT05874466: Recruiting study of Autism Spectrum Disorder and Autism, sponsored by Duke University.
NCT05874466 is a study of Autism Spectrum Disorder and Autism that is actively recruiting participants, run by Duke University. The registered enrollment target is 350 participants, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (161% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05874466, a study of Autism Spectrum Disorder and Autism, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- 350 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Sensitivity = #participants positive for autism on both (1) the SenseToKnow screening device based on a machine learning algorithm that combines SenseToKnow digital data with the SenseToKnow Caregiver Survey data and (2) expert clinical diagnosis / #participants positive for autism on both SenseToKnow and expert clinical diagnosis
Conditions Studied
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2023-07-07 |
| Est. Completion | 2027-12 |
What NCT05874466 shows while recruiting
NCT05874466 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (161% higher).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT05874466 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05874466 about?
NCT05874466 is a clinical study titled "SenseToKnow Autism Screening Device Validation Study". 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.
What is the current status of trial NCT05874466?
This trial is currently recruiting. The enrollment target is 350 participants. The study started on 2023-07-07. Estimated completion is 2027-12.
What conditions does trial NCT05874466 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.
Who is sponsoring clinical trial NCT05874466?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05874466 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05874466's enrollment target sits among peer trials
350 21st of 224 higher than 203 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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