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NCT06282289 Clinical Trial

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

Speech Clinical Trial

— AV-SSR-I  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06282289
Other study ID # 2023-077
Secondary ID 2023-A01798-37
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date September 21, 2025

Study information
Verified date January 2024
Source Institut Pasteur
Contact Sophie Bouton, PhD
Phone 0176535072
Email sophie.bouton@pasteur.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 64
Est. completion date September 21, 2025
Est. primary completion date September 21, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 10 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Magnetoencephalography (MEG)
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.
Other:
• Cognition development questionnaire
Computerised questionnaires completed by parents

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Institut Pasteur Institut de l'Audition

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 at 10- and 6-months of age
Secondary 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 4 experimental conditions : AV synchronous coherent, AV asynchronous coherent, AV synchronous incoherent, and AV asynchronous incoherent at 10- and 6-months of age
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