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

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ClinicalTrials.gov Identifier: NCT04326231
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Cognoa, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Usability assessment of Cognoa ASD Therapeutic Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cognoa ASD Digital Therapeutic Engagement and Usability Study
Actual Study Start Date : March 17, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device
 Device: Usability assessment of Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device


Outcome Measures
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Primary Outcome Measures :
  1. Usability assessment of Cognoa ASD Therapeutic Device [ Time Frame: 4 weeks ]
    Device usability metrics are measured by weekly survey (e.g. ease of use for child, frustration level, fatigue).


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326231


Contacts
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Contact: Kelley Abrams, PhD 408-207-6659 kelley.abrams@cognoa.com

Locations
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United States, California
Cognoa Recruiting
Palo Alto, California, United States, 94306
Contact: Kelley Abrams, PhD         
Sponsors and Collaborators
Cognoa, Inc.
Investigators
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Principal Investigator: Kelley Abrams, PhD Cognoa, Inc.
More Information
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Responsible Party: Cognoa, Inc.
ClinicalTrials.gov Identifier: NCT04326231    
Other Study ID Numbers: PRO-003
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders