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Completed

NCT Number: NCT04151290

Cognoa ASD Diagnosis Aid Validation Study

The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Melmed Center, Scottsdale, Arizona, United States

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About this study

To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General Inclusion Criteria:

  • Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
  • Caregiver or HCP concern for developmental delay.
  • Female or Male, >18 to <72 months of age

General Exclusion Criteria:

  • Subjects with a prior diagnosis of ASD rendered by a healthcare professional.
  • Subjects whose age on the date of enrollment is outside the target age range.
  • Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.

Treatment and study plan

Cognoa ASD diagnostic device

Diagnostic Test

Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)

Primary outcomes

  1. Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation

    Time frame: 6 Weeks

    Achievement of a composite of positive predictive value (PPV) greater than 65% and negative predictive value (NPV) greater than 85% for the device in relation to the clinical reference standard in the overall study population:

  2. No Result Percentage

    Time frame: 6 Weeks

    Measurement of the percentage of children for whom the device has provided no result.

Secondary outcomes

  1. Device Sensitivity and Specificity

    Time frame: 6 Weeks

    Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.

Sponsors and collaborators

Lead sponsor

Cognoa, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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