Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants (AV-SSR-I)

March 5, 2024 updated by: Institut Pasteur

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 6-month-old infants
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
Other: 10-month-old infants
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: at 10-months, 6-months and 18-months of age
at 10-months, 6-months and 18-months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 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 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
at 10- and 6-months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

Institut de l'Audition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 21, 2025

Study Completion (Estimated)

September 21, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-077
  • 2023-A01798-37 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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