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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 30, 2020
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE March 17, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study
Official Title  ICMJE Cognoa ASD Digital Therapeutic Engagement and Usability Study
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE Device: Usability assessment of Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device
Study Arms  ICMJE Experimental: Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device
Intervention: Device: Usability assessment of Cognoa ASD Therapeutic Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kelley Abrams, PhD 408-207-6659 kelley.abrams@cognoa.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04326231
Other Study ID Numbers  ICMJE PRO-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cognoa, Inc.
Study Sponsor  ICMJE Cognoa, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kelley Abrams, PhD Cognoa, Inc.
PRS Account Cognoa, Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP