Cognoa ASD Diagnostic Device - Data Collection Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Diagnostic test: ASD Diagnostic Device

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation	approximately one month

Collaborators and Investigators

• Sponsor: Cognoa, Inc.
• Investigators: Principal Investigator: Tom Megerian, MD, Children's Hospital of Orange County

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): August 12, 2019
• Study Completion (Actual): August 12, 2019

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: March 9, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 1189568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No