Autism Spectrum DisorderNCT03871179
Cognoa ASD Diagnostic Device - Data Collection Study
A study testing ASD Diagnostic Device in people with Autism Spectrum Disorder, run by Cognoa, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions. Read more about this study
- Who is it for?
- Ages 18 to 72 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ASD Diagnostic Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to 12 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 18 months of age and < 72 months of age
- Functional English capability in the home environment
- Documented parental and/or clinician concern for developmental delay
- Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)
Who cannot join
- Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
- Children with known sensory impairment such as deafness or blindness
- Children with known physical impairment affecting their ability to use their hands
- Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome)
- Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X)
- Children with microcephaly
Show all 12Show fewer
- Children with history or prior diagnosis of epilepsy or seizures
- Children with history of or suspected neglect
- Children with history of brain defect, injury or insult requiring interventions such as surgery or chronic medication
- Children whose age on the date of enrollment is outside the target age range
- Children who have been previously enrolled in any Cognoa clinical study or survey
- Children whose medical records had been included in any internal Cognoa training or validation sets
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Orange County
Orange, California, 92868
About this study
The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.
- Conditions
- Autism Spectrum Disorder
- Being tested
- ASD Diagnostic Device
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD Diagnostic DeviceDiagnostic test
The ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the "Cognoa App", used outside of a clinical setting
| Study group | Role | What they receive |
|---|---|---|
| ASD Diagnostic Device | Other | The ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the "Cognoa App", used outside of a clinical setting Receives: Diagnostic Test: ASD Diagnostic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation
Measured: approximately one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start23 Jan 2019
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognoa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Megerian, MD, Principal investigator, Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871179
- Sponsor's protocol ID
- 1189568
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2019
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognoa ASD Diagnostic Device - Data Collection Study
- ClinicalTrials.gov ID
- NCT03871179
- Acronym / sponsor ID
- 1189568
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cognoa, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD Diagnostic Device | Other | Diagnostic Test: ASD Diagnostic DeviceThe ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the "Cognoa App", used outside of a clinical setting |
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ≥ 18 months of age and < 72 months of age
- Functional English capability in the home environment
- Documented parental and/or clinician concern for developmental delay
- Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)
Key exclusion criteria (12 listed)
- Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
- Children with known sensory impairment such as deafness or blindness
- Children with known physical impairment affecting their ability to use their hands
- Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome)
- Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASD Diagnostic DeviceThe ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the "Cognoa App", used outside of a clinical setting | Diagnostic test | ASD Diagnostic Device |
Primary outcome
Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation
Time frame: approximately one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Megerian, MD principal investigator
Children's Hospital of Orange County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASD Diagnostic Device in people with Autism Spectrum Disorder, run by Cognoa, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation (time frame: approximately one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.