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NCT Number: NCT06282289

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

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.

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Key information

Conditions

Speech Behavior Communication Verbal Behavior

Age range

6 month–10 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetoencephalography (MEG)

Behavioral

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.

Cognition development questionnaire

Other

Computerised questionnaires completed by parents

Primary outcomes

  1. 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.

    Time frame: at 10-months, 6-months and 18-months of age

Secondary outcomes

  1. 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 inputs

    Time frame: at 10- and 6-months of age

  2. 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 inputs

    Time frame: at 10- and 6-months of age

    4 experimental conditions : AV synchronous coherent, AV asynchronous coherent, AV synchronous incoherent, and AV asynchronous incoherent

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Lise Giraud, PhD

CONTACT

[email protected]

0176535054 ext. +33

Sophie Bouton, PhD

CONTACT

[email protected]

0176535072 ext. +33

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Institut de l'Audition

Registry information

Acronym: AV-SSR-I

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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