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Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants

Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06282289
Acronym
AV-SSR-I
Enrollment
64
Registered
2024-02-28
Start date
2025-05-31
Completion date
2025-09-21
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech

Brief summary

The goal of this study is to investigate the preferential responses of speech neural systems in infants. The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary). Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz.

Interventions

Stimuli will be presented binaurally through headphones at 60 decibel sound pressure level (dB SPL). Conditions are presented in a pseudo-random order with an inter-stimulus interval of \ 800 ms on average (range: 600 ms to 1000 ms). The duration of the stimuli is fixed: 2 seconds, in order to guarantee a minimum number of cycles.

OTHERCognition development questionnaire

Computerised questionnaires completed by parents

Sponsors

Institut de l'Audition
CollaboratorOTHER
Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 10 Months
Healthy volunteers
Yes

Inclusion criteria

* be 6 or 10 months old (+/- 2 weeks) * have received age-appropriate information on the experiment * their legal guardians have received appropriate information and given their oral consent.

Exclusion criteria

* A neurological disorder (visual, auditory, motor, executive) * Developmental delay

Design outcomes

Primary

MeasureTime frame
Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age.at 10-months, 6-months and 18-months of age

Secondary

MeasureTime frameDescription
The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputsat 10- and 6-months of age
The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputsat 10- and 6-months of age4 experimental conditions : AV synchronous coherent, AV asynchronous coherent, AV synchronous incoherent, and AV asynchronous incoherent

Contacts

Primary ContactSophie Bouton, PhD
sophie.bouton@pasteur.fr0176535072
Backup ContactAnne-Lise Giraud, PhD
anne-lise.giraud-mamessier@pasteur.fr0176535054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026