Status:
TERMINATED
Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study
Lead Sponsor:
Cognoa, Inc.
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
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.
Detailed Description
Parents who consent will be given access to the study device through its caregiver and child-facing smartphone app that provides therapeutic content. In order to access the study device app, parents w...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04326231
Start Date
March 17 2020
End Date
July 31 2020
Last Update
September 21 2023
Active Locations (1)
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1
Cognoa
Palo Alto, California, United States, 94306