Autism Spectrum DisorderSIRCUSNCT05596331
Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation
A study testing eye-tracker in people with Autism Spectrum Disorder, run by University Hospital, Tours at 1 site in France.
Trial summary
The goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). Read more about this study
- Who is it for?
- Ages 1 day to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- eye-tracker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2023to 2 Nov 2026
- Phase
- Interventional
- 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 1 day to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Phase 1
- All groups have these 2 criteria in common:
- Free, informed and signed consent of both parents Enrolment in the social security system
- The other criteria per group are as follows:
- Group of adult subjects without ASD : Age between 18 and 50 years Group of children without ASD
- Age between 2 and 12 years
Show all 11Show fewer
- Group of children with ASD Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11
- Phase 2
- Group of children without TND : Age between 0 and 12 years
- Group of children with TND, or whose diagnosis is in progress (via PCO referral) :
- Age between 0 and 12 years Conformity to the diagnostic criteria of TND
Who cannot join
- Phase 1:
- All groups have the 2 common exclusion criteria Known uncorrected visual pathologies Known personal neurological pathologies
- And they have these criteria per group:
- Group of adult subjects without ASD: Subject under guardianship or trusteeship Diagnosis of ASD Group of children without ASD : Diagnosis of ASD
- Group of children with ASD ICD-10 diagnosis of PDD (Rett syndrome and Hayler syndrome) Phase 2
- Group of children without ASD : Diagnosis of ASD (confirmed or ongoing)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pédopsychiatrie-CHU-TOURS
Tours, 37044
Nadia AGUILLON-HERNANDEZ, PhD, +33247478840, nadia.aguillon@univ-tours.fr
About this study
Official title: SIRCUS : Social Information pRocessing in Children:an ocUlo-pupillometric Tool for Standard Evaluation
The goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.
Read the detailed description
In a first phase (expected to last 12-16 months), after an experimental validation in typical adults, relevant oculometric and pupillometric indices will be identified in a typical population of children and in a clinically diagnosed population of ASD children.
In a second phase of the protocol (expected to last 32-36 months), biomarkers identified in the first phase will be tested on a larger population including other neurodevelopmental disorders.
- Conditions
- Autism Spectrum Disorder
- Being tested
- eye-tracker
- 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.
eye-trackerOther
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
| Study group | Role | What they receive |
|---|---|---|
| Group of adult subjects without ASD (Autism Spectrum Disorders) | Other | Age between 18 and 50 years Receives: Other: eye-tracker |
| Group of children without ASD | Other | Age between 2 and 12 years Receives: Other: eye-tracker |
| Group of children with ASD | Other | Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11 Receives: Other: eye-tracker |
| Group of children without NDD (NeuroDevelopmental Disorders) | Other | Age between 0 and 12 years Receives: Other: eye-tracker |
| Group of children with NDD, or whose diagnosis is in progress | Other | Conformity to the diagnostic criteria of NDD Receives: Other: eye-tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oculometric measurements 1: Tracking time
Mean of tracking time (ms) during entire stimuli duration
Measured: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Oculometric measurements 2: Fixation time on the screen
Mean of fixation time on the screen (ms) during entire stimuli duration
Measured: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration
Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration
Measured: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Oculometric measurements 4: Fixation time on the mouth area of face stimuli
Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration
Measured: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Pupillometric measurements
Mean of pupil dilation variation(mm) in response to entire stimuli duration
Measured: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Discriminative power
AUROC (Area Under the Receiver Operating Characteristics, in percent) analysis of combined oculometric and pupillometric measurements. Scale score : 0-100% (above 70% : good performance; above 80% : excellent performance; above 90% : outstanding performance)
Measured: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start3 Jan 2023
- Primary completion3 Jan 2026
- Study completion2 Nov 2026 (estimated)
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- UMR 1253, iBrain, Université de Tours, Inserm, Tours, France., Laboratory of Fundamental and Applied Computer Science of Tours, EA6300, National Research Agency, France, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Nadia Aguillon-Hernandez, MCU, Principal investigator, UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596331
- Sponsor's protocol ID
- DR220031/SIRCUS
- Other IDs
- 2022-A00870-43
- Acronym
- SIRCUS
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2022
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIRCUS : Social Information pRocessing in Children:an ocUlo-pupillometric Tool for Standard Evaluation
- ClinicalTrials.gov ID
- NCT05596331
- Acronym / sponsor ID
- SIRCUS / DR220031/SIRCUS
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- UMR 1253, iBrain, Université de Tours, Inserm, Tours, France., Laboratory of Fundamental and Applied Computer Science of Tours, EA6300, National Research Agency, France, Ministry of Health, France
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 27 Oct 2022 (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 goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.
Detailed description
In a first phase (expected to last 12-16 months), after an experimental validation in typical adults, relevant oculometric and pupillometric indices will be identified in a typical population of children and in a clinically diagnosed population of ASD children.
In a second phase of the protocol (expected to last 32-36 months), biomarkers identified in the first phase will be tested on a larger population including other neurodevelopmental disorders.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group of adult subjects without ASD (Autism Spectrum Disorders) | Other | Other: eye-trackerAge between 18 and 50 years |
| Group of children without ASD | Other | Other: eye-trackerAge between 2 and 12 years |
| Group of children with ASD | Other | Other: eye-trackerAge between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11 |
| Group of children without NDD (NeuroDevelopmental Disorders) | Other | Other: eye-trackerAge between 0 and 12 years |
| Group of children with NDD, or whose diagnosis is in progress | Other | Other: eye-trackerConformity to the diagnostic criteria of NDD |
Who may qualify
- Ages
- 1 day to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Phase 1
- Free, informed and signed consent of both parents Enrolment in the social security system
- Group of adult subjects without ASD : Age between 18 and 50 years Group of children without ASD
- Age between 2 and 12 years
- Group of children with ASD Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11
Key exclusion criteria (6 listed)
- All groups have the 2 common exclusion criteria Known uncorrected visual pathologies Known personal neurological pathologies
- Group of adult subjects without ASD: Subject under guardianship or trusteeship Diagnosis of ASD Group of children without ASD : Diagnosis of ASD
- Group of children with ASD ICD-10 diagnosis of PDD (Rett syndrome and Hayler syndrome) Phase 2
- Group of children without ASD : Diagnosis of ASD (confirmed or ongoing)
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 |
|---|---|---|
| eye-trackerEye-tracker recordings of eye movements, gaze direction and pupillary reactivity | Other | Group of adult subjects without ASD (Autism Spectrum Disorders), Group of children with ASD, Group of children with NDD, or whose diagnosis is in progress, Group of children without ASD, Group of children without NDD (NeuroDevelopmental Disorders) |
Primary outcome
Oculometric measurements 1: Tracking time
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Mean of tracking time (ms) during entire stimuli duration
Oculometric measurements 2: Fixation time on the screen
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Mean of fixation time on the screen (ms) during entire stimuli duration
Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration
Oculometric measurements 4: Fixation time on the mouth area of face stimuli
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration
Pupillometric measurements
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Mean of pupil dilation variation(mm) in response to entire stimuli duration
Discriminative power
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
AUROC (Area Under the Receiver Operating Characteristics, in percent) analysis of combined oculometric and pupillometric measurements. Scale score : 0-100% (above 70% : good performance; above 80% : excellent performance; above 90% : outstanding performance)
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 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Nadia Aguillon-Hernandez, MCU principal investigator
UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye-tracker in people with Autism Spectrum Disorder, run by University Hospital, Tours at 1 site in France.
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 11 inclusion and 6 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 28 Aug 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 France. 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 Nadia Aguillon-Hernandez, MCU (0247478840, nadia.aguillon@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oculometric measurements 1: Tracking time (time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)). The study lists 6 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 28 Aug 2026.