AutismNCT07590973
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
An observational study of Autism and Autism Spectrum Disorder, run by Blinklab Limited at 1 site in United States.
Trial summary
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. Read more about this study
- Who is it for?
- Ages 2 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD)
- What is being tested?
- BlinkLab Dx1 and Retrospective Neurodevelopmental Diagnostic Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 2-11 years of which the parents/caregivers and/or pediatrician (or other primary care provider) have raised concerns regarding their neurodevelopment and have undergone neurodevelopmental assessment in the last 12 months that would allow diagnosing any neurodevelopmental condition according to DSM5 criteria.
Who may be able to join
- Age: Children between 2 to 11 years old
- Parent/Caregiver/Healthcare Provider Concern: The child has received a diagnostic outcome of a neurodevelopmental assessment based on DSM-5 criteria within the past 12 months.
- Language Proficiency: Parents and subjects must have functional English capability in the home environment.
- Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).
- Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.
Who cannot join
- Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.
- Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.
- Location of at home testing: Not being able to complete all remote at-home study sessions within the US.
- History of audiogenic seizures: Participants with a known history of seizures that are triggered by auditory stimuli, including reflex or startle epilepsy provoked by sounds (audiogenic seizures), or any other form of sound-induced epilepsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Remote study conducted nationwide; all participation occurs via smartphone app at home.
Princeton, New Jersey, 08540
Myrthe J. Ottenhoff, MD, PhD, 908-824-3471, study@blinklab.org
About this study
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. BlinkLab Dx1 is a non-invasive, smartphone-based application under development as a diagnostic aid for healthcare providers assessing autism.
In this study, children who have undergone a neurodevelopmental assessment within the past 12 months will complete two short, video-based sessions using the BlinkLab Dx1 app. The app presents visual and auditory stimuli and records reflexive sensorimotor responses and patterns of repetitive behavior. Additionally, primary caregivers will answer a short questionnaire in the app about symptoms and development. Information about prior neurodevelopmental assessments, including documented DSM-5-based diagnoses from routine clinical practice, will be collected retrospectively.
Read more
The study will examine how the app's neurobehavioral measurements relate to previously assigned clinical diagnoses. These paired data will be used to develop and evaluate a machine learning-based algorithm using separate training and testing datasets to assess whether patterns measured by BlinkLab Dx1 can help distinguish children with autism from children without an autism diagnosis.
This study does not involve any treatment or medical intervention.
Read the detailed description
Specification of the Time Perspective section in the Study Design: this study has a hybrid time perspective, as BlinkLab Dx1 measures are collected prospectively during remote sessions, while the clinical reference standard (presence of in a DSM-5-based diagnostic report from a neurodevelopmental assessment within the prior 12 months) is collected retrospectively. The clinical reference standard is based on neurodevelopmental assessments conducted in routine clinical care and is collected without influence from study procedures.
The study will use paired BlinkLab Dx1 measurements and clinical reference standard diagnoses to develop and evaluate a machine learning-based classification algorithm. The dataset will be divided into separate training and testing subsets, with the training dataset used to develop the model and determine classification thresholds, and the independent testing dataset used to evaluate diagnostic performance. The model will generate a classification categorizing participants as "Positive for autism", "Intermediate" or "Negative for autims". Participants with intermediate results are considered to have indeterminate findings and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions
- Being tested
- BlinkLab Dx1, Retrospective Neurodevelopmental Diagnostic Assessment
- Keywords
- Autism Spectrum Disorder, Autism, Autism Diagnosis, Neurodevelopmental Conditions, Pediatric Assessment, Digital Assessment, Mobile Application, Smartphone-based Assessment, Digital Health, Remote Study, Observational Study, Eye Movements, Repetitive Behavior, Reflexive Sensorimotor Behavior, Machine Learning
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinkLab Dx1Diagnostic test
BlinkLab Dx1 is a machine learning-based algorithm that generates a continuous score reflecting likelihood of autism from neurobehavioral responses (including measures such as pre-pulse inhibition and habituation, motor activity, and vocalizations) recorded during standardized video-watching sessions in a mobile application. Pre-specified thresholds, determined during model development and fixed prior to evaluation in the independent test dataset, are applied to categorize results as " Positive for autism", "Intermediate" or "Nagative for autism". Results in the intermediate category are considered indeterminate and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
Retrospective Neurodevelopmental Diagnostic AssessmentBehavioural
The clinical reference standard is a retrospective neurodevelopmental diagnostic assessment conducted within 12 months prior to enrollment, based on DSM-5 criteria. Participants are classified as having or not having an autism diagnosis based on the documented diagnostic conclusions of these assessments.
| Study group | Role | What they receive |
|---|---|---|
| Model Development Group - Children evaluated for neurodevelopmental conditions. | Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition. Receives: Diagnostic Test: BlinkLab Dx1; Behavioral: Retrospective Neurodevelopmental Diagnostic Assessment | |
| Model Testing Group - Children evaluated for neurodevelopmental conditions. | Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition. Data collection for this group is blinded. Receives: Diagnostic Test: BlinkLab Dx1; Behavioral: Retrospective Neurodevelopmental Diagnostic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of BlinkLab Dx1
Sensitivity of BlinkLab Dx1, defined as the proportion of participants with a positive clinical reference standard diagnosis of autism who are correctly identified as positive by the index test.
Measured: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Specificity of BlinkLab Dx1
Specificity of the BlinkLab Dx1 algorithm, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are correctly identified as negative by the index test.
Measured: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Secondary outcomes (8)
Adverse Events
A qualitative description of any adverse events that occurred during the study from the time of informed consent until the completion of the diagnostic evaluation.
Measured: During individual enrollment period (up to 30 days)
Usability
The usability of the device for parents/caregivers in relation to the use-related risk analysis identified risks.
Measured: During the individual enrollment period (up to 30 days)
Autism Symptom Severity
Based on prospectively collected SRS-2 questionnaire scores and retrospectively collected standardized autism assessment results documented in the neurodevelopmental assessment report.
Measured: Baseline (including neurodevelopmental assessment data from up to 12 months prior to enrollment and a single SRS-2 assessment collected once during the enrollment period [up to 30 days after enrollment])
Positive Predictive Value (PPV) of BlinkLab Dx1
Positive predictive value, defined as the proportion of participants with a positive BlinkLab Dx1 test result who have a positive clinical reference standard diagnosis of autism.
Measured: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Negative Predictive Value of BlinkLab Dx1
Negative predictive value, defined as the proportion of participants with a negative BlinkLab Dx1 test result who do not have a clinical reference standard diagnosis of autism.
Measured: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False Positive Rate of BlinkLab Dx1
False positive rate, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are incorrectly identified as positive by the BlinkLab Dx1 index test.
Measured: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False Negative Rate of BlinkLab Dx1
False negative rate, defined as the proportion of participants with a clinical reference standard diagnosis of autism who are incorrectly identified as negative by the BlinkLab Dx1 index test.
Measured: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Accuracy of BlinkLab Dx1
Accuracy, defined as the proportion of all participants who are correctly classified by the BlinkLab Dx1 index test (i.e., the sum of true positives and true negatives divided by the total number of participants), relative to the clinical reference standard diagnosis.
Measured: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Feb 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blinklab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590973
- Sponsor's protocol ID
- 08012025
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: BlinkLab is a publicly listed company holding patents related to the BlinkLab Dx technology. The sponsor intends to evaluate mechanisms for sharing de-identified, non-proprietary participant-level data with qualified academic investigators under data use agreements that protect participant privacy and BlinkLab's intellectual property. Any shared data will exclude raw video, audio, or algorithmic outputs that are proprietary or potentially identifiable.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
- ClinicalTrials.gov ID
- NCT07590973
- Acronym / sponsor ID
- 08012025
- Conditions
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions
- Keywords
- Autism Spectrum Disorder, Autism, Autism Diagnosis, Neurodevelopmental Conditions, Pediatric Assessment, Digital Assessment, Mobile Application, Smartphone-based Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Blinklab LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 May 2026 (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.
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. BlinkLab Dx1 is a non-invasive, smartphone-based application under development as a diagnostic aid for healthcare providers assessing autism.
In this study, children who have undergone a neurodevelopmental assessment within the past 12 months will complete two short, video-based sessions using the BlinkLab Dx1 app. The app presents visual and auditory stimuli and records reflexive sensorimotor responses and patterns of repetitive behavior. Additionally, primary caregivers will answer a short questionnaire in the app about symptoms and development. Information about prior neurodevelopmental assessments, including documented DSM-5-based diagnoses from routine clinical practice, will be collected retrospectively.
The study will examine how the app's neurobehavioral measurements relate to previously assigned clinical diagnoses. These paired data will be used to develop and evaluate a machine learning-based algorithm using separate training and testing datasets to assess whether patterns measured by BlinkLab Dx1 can help distinguish children with autism from children without an autism diagnosis.
This study does not involve any treatment or medical intervention.
Detailed description
Specification of the Time Perspective section in the Study Design: this study has a hybrid time perspective, as BlinkLab Dx1 measures are collected prospectively during remote sessions, while the clinical reference standard (presence of in a DSM-5-based diagnostic report from a neurodevelopmental assessment within the prior 12 months) is collected retrospectively. The clinical reference standard is based on neurodevelopmental assessments conducted in routine clinical care and is collected without influence from study procedures.
The study will use paired BlinkLab Dx1 measurements and clinical reference standard diagnoses to develop and evaluate a machine learning-based classification algorithm. The dataset will be divided into separate training and testing subsets, with the training dataset used to develop the model and determine classification thresholds, and the independent testing dataset used to evaluate diagnostic performance. The model will generate a classification categorizing participants as "Positive for autism", "Intermediate" or "Negative for autims". Participants with intermediate results are considered to have indeterminate findings and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model Development Group - Children evaluated for neurodevelopmental conditions. | – | Diagnostic Test: BlinkLab Dx1, Behavioral: Retrospective Neurodevelopmental Diagnostic AssessmentChildren aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition. |
| Model Testing Group - Children evaluated for neurodevelopmental conditions. | – | Diagnostic Test: BlinkLab Dx1, Behavioral: Retrospective Neurodevelopmental Diagnostic AssessmentChildren aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition. Data collection for this group is blinded. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-11 years of which the parents/caregivers and/or pediatrician (or other primary care provider) have raised concerns regarding their neurodevelopment and have undergone neurodevelopmental assessment in the last 12 months that would allow diagnosing any neurodevelopmental condition according to DSM5 criteria.
Key inclusion criteria (5 listed)
- Age: Children between 2 to 11 years old
- Parent/Caregiver/Healthcare Provider Concern: The child has received a diagnostic outcome of a neurodevelopmental assessment based on DSM-5 criteria within the past 12 months.
- Language Proficiency: Parents and subjects must have functional English capability in the home environment.
- Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).
- Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.
Key exclusion criteria (4 listed)
- Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.
- Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.
- Location of at home testing: Not being able to complete all remote at-home study sessions within the US.
- History of audiogenic seizures: Participants with a known history of seizures that are triggered by auditory stimuli, including reflex or startle epilepsy provoked by sounds (audiogenic seizures), or any other form of sound-induced epilepsy.
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 |
|---|---|---|
| BlinkLab Dx1BlinkLab Dx1 is a machine learning-based algorithm that generates a continuous score reflecting likelihood of autism from neurobehavioral responses (including measures such as pre-pulse inhibition and habituation, motor activity, and vocalizations) recorded during standardized video-watching sessions in a mobile application. Pre-specified thresholds, determined during model development and fixed prior to evaluation in the independent test dataset, are applied to categorize results as " Positive for autism", "Intermediate" or "Nagative for autism". Results in the intermediate category are considered indeterminate and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results. | Diagnostic test | Model Development Group - Children evaluated for neurodevelopmental conditions., Model Testing Group - Children evaluated for neurodevelopmental conditions. |
| Retrospective Neurodevelopmental Diagnostic AssessmentThe clinical reference standard is a retrospective neurodevelopmental diagnostic assessment conducted within 12 months prior to enrollment, based on DSM-5 criteria. Participants are classified as having or not having an autism diagnosis based on the documented diagnostic conclusions of these assessments. | Behavioural | Model Development Group - Children evaluated for neurodevelopmental conditions., Model Testing Group - Children evaluated for neurodevelopmental conditions. |
Primary outcome
Sensitivity of BlinkLab Dx1
Time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Sensitivity of BlinkLab Dx1, defined as the proportion of participants with a positive clinical reference standard diagnosis of autism who are correctly identified as positive by the index test.
Specificity of BlinkLab Dx1
Time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Specificity of the BlinkLab Dx1 algorithm, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are correctly identified as negative by the index test.
8 secondary outcomes
Adverse Events
Time frame: During individual enrollment period (up to 30 days)
Usability
Time frame: During the individual enrollment period (up to 30 days)
Autism Symptom Severity
Time frame: Baseline (including neurodevelopmental assessment data from up to 12 months prior to enrollment and a single SRS-2 assessment collected once during the enrollment period [up to 30 days after enrollment])
Positive Predictive Value (PPV) of BlinkLab Dx1
Time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Negative Predictive Value of BlinkLab Dx1
Time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False Positive Rate of BlinkLab Dx1
Time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False Negative Rate of BlinkLab Dx1
Time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Accuracy of BlinkLab Dx1
Time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided. BlinkLab is a publicly listed company holding patents related to the BlinkLab Dx technology. The sponsor intends to evaluate mechanisms for sharing de-identified, non-proprietary participant-level data with qualified academic investigators under data use agreements that protect participant privacy and BlinkLab's intellectual property. Any shared data will exclude raw video, audio, or algorithmic outputs that are proprietary or potentially identifiable.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Autism Spectrum Disorder, run by Blinklab Limited 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myrthe J. Ottenhoff, MD, PhD (908-824-3471, study@blinklab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of BlinkLab Dx1 (time frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)). The study lists 2 primary outcomes in all. 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 15 May 2026.