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RecruitingNCT05596331SIRCUSUpdated Aug 28, 2026

Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation

An interventional study of eye-tracker in Autism Spectrum Disorder, sponsored by University Hospital, Tours. Recruiting at 1 site in France. Open to participants aged 1 Day to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by University Hospital, Tours · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
460
Allocation
Non-randomized
Ages
1 Day to 50 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Autism Spectrum Disorder
03

Who can participate

Ages eligible
1 Day to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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
  • 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

Exclusion criteria

Exclusion Criteria:

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)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
460 participants (estimated)

Study arms

  • Other
    Group of adult subjects without ASD (Autism Spectrum Disorders)

    Age between 18 and 50 years

    Other: eye-tracker

  • Other
    Group of children without ASD

    Age between 2 and 12 years

    Other: eye-tracker

  • Other
    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

    Other: eye-tracker

  • Other
    Group of children without NDD (NeuroDevelopmental Disorders)

    Age between 0 and 12 years

    Other: eye-tracker

  • Other
    Group of children with NDD, or whose diagnosis is in progress

    Conformity to the diagnostic criteria of NDD

    Other: eye-tracker

Interventions

  • Othereye-tracker

    Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity

05

What researchers measure

Primary outcomes

  1. Oculometric measurements 1: Tracking time

    Mean of tracking time (ms) during entire stimuli duration

    Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)

  2. Oculometric measurements 2: Fixation time on the screen

    Mean of fixation time on the screen (ms) during entire stimuli duration

    Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)

  3. 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

    Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)

  4. 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

    Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)

  5. Pupillometric measurements

    Mean of pupil dilation variation(mm) in response to entire stimuli duration

    Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)

  6. 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)

    Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)

06

Study locations

1 of 1 sites recruiting
  • Service de Pédopsychiatrie-CHU-TOURS
    Tours, 37044, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05596331
Lead sponsor
University Hospital, Tours
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
First posted
Oct 27, 2022
Start date
Jan 3, 2023
Primary completion
Jan 3, 2026
Completion
Nov 2, 2026 (estimated)
Last update
Aug 28, 2026

Study contacts

Nadia Aguillon-Hernandez, MCU
Contact
nadia.aguillon@univ-tours.fr
0247478840
Yosra DRIDI
Contact
Y.ABDERRAHMEN@chu-tours.fr
+33247479792
Nadia Aguillon-Hernandez, MCU
principal investigator · UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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