Cognoa ASD Diagnostic Device - Data Collection Study

NCT ID: NCT03871179

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-23
• Study Completion Date: 2019-08-12

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

ASD Diagnostic Device

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cognoa, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Megerian, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Orange County

Locations

Children's Hospital of Orange County

Orange, California, United States

Countries

United States

Other Identifiers

1189568

Identifier Type: -

Identifier Source: org_study_id