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
• 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
• 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

Related Conditions & MeSH terms

• Speech

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