Cognoa ASD Diagnostic Device - Data Collection Study

Autism Spectrum Disorder Clinical Trial

Official title:

Cognoa ASD Diagnostic Device - Data Collection Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03871179
• Other study ID #: 1189568
• Status: Withdrawn
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: August 12, 2019

Study information

• Verified date: February 2024
• Source: Cognoa, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 72 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Orange County	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Cognoa, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation		approximately one month