SenseToKnow Autism Screening Device Validation Study

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05874466
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Months - 36 Months
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 7, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Pediatric patients, 16-36 months of age, recruited through pediatric medical clinics
    Consecutive pediatric participants will be recruited and enrolled via \>= 6 participating sites comprised of pediatric medical clinics (e.g., primary care and family medicine clinics) that are part of the broader Duke University Health System (DUHS) located in North Carolina. Enrollment will proceed until the targets of N = 150 participants diagnosed with autism spectrum disorder and N = 200 without autism are reached.

Primary Outcome Measure

Sensitivity of the SenseToKnow screening device based on a machine learning algorithm that combines SenseToKnow digital data with data from the SenseToKnow Caregiver survey for autism detection [ Time Frame: Will be calculated based on data from Baseline/Timepoint 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Geraldine Dawson, PhD
919-668-0070

Find similar trials in Durham, NC

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Duke University· Durham, NC

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