Status:
WITHDRAWN
Cognoa ASD Diagnostic Device - Data Collection Study
Lead Sponsor:
Cognoa, Inc.
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
18-72 years
Phase:
NA
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 add...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03871179
Start Date
January 23 2019
End Date
August 12 2019
Last Update
February 8 2024
Active Locations (1)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868