Cognoa ASD Diagnostic Device - Data Collection Study

Not Applicable

Withdrawn

• Conditions: Autism Spectrum Disorder
• Interventions: Diagnostic Test: ASD Diagnostic Device

• Registration Number: NCT03871179
• Lead Sponsor: Cognoa, Inc.

Brief Summary

The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-23
• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-09
• Study First Posted: 2019-03-12
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ≥ 18 months of age and < 72 months of age
• Functional English capability in the home environment
• Documented parental and/or clinician concern for developmental delay
• Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)

Exclusion Criteria

• Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
• Children with known sensory impairment such as deafness or blindness
• Children with known physical impairment affecting their ability to use their hands
• Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome)
• Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X)
• Children with microcephaly
• Children with history or prior diagnosis of epilepsy or seizures
• Children with history of or suspected neglect
• Children with history of brain defect, injury or insult requiring interventions such as surgery or chronic medication
• Children whose age on the date of enrollment is outside the target age range
• Children who have been previously enrolled in any Cognoa clinical study or survey
• Children whose medical records had been included in any internal Cognoa training or validation sets

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASD Diagnostic Device	ASD Diagnostic Device	The ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the "Cognoa App", used outside of a clinical setting

Primary Outcome Measures

Name	Time	Method
Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation	approximately one month

Trial Locations

Locations (1)

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States