Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study

Stopped early · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

Cognoa will measure usability, engagement with the device, and changes in parent-reported socialization during a 4-week period of intervention at home with the Cognoa ASD therapeutic device.

Key facts

Study ID

NCT04326231

Run by

Cognoa, Inc.

People needed

10

Starts

2020-03-17

Expected to finish

2020-07-31

Last updated by the study team

2023-09-21

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Functional English language capability in the home environment.
• Parent, Guardian, or legal authorized representative (LAR) must be able to read, understand and sign the Informed Consent Form (ICF)
• Female or Male, > 3 to < 9 years of age and parent/caregiver
• Diagnosis of Autism Spectrum Disorder, within the last 12 months
• Parent, Guardian, or legal authorized representative (LAR) must have smartphone capabilities for downloading Testflight software; test versions of the Cognoa for Child development app; and test versions of the Cognoa Digital Therapeutic app (iOS 12.0 and up and Apple iPhone 8 and higher)

You may not qualify if…

• Participants with any other medical, behavioral, or developmental condition that in the opinion of the investigator may confound study data/assessments.
• Participants with planned extensive travel (more than 1 week) during the course of the 4 week intervention time period.
• Participants with deafness or blindness.
• Participants with known physical impairments affecting their ability to use their hands.
• Participants with active diagnosis of epilepsy and uncontrolled seizures.
• Participants whose age on the date of enrollment is outside the target age range

Where it is running

• Cognoa — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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