Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants (AV-SSR-I)
February 28, 2025 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
- Name: Sophie Bouton, PhD
- Phone Number: +33 0176535072
- Email: sophie.bouton@pasteur.fr
Study Contact Backup
- Name: Anne-Lise Giraud, PhD
- Phone Number: +33 0176535054
- Email: anne-lise.giraud-mamessier@pasteur.fr
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
|
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.
Computerised questionnaires completed by parents
|
|
Other: 10-month-old infants
|
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.
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
Collaborators
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)
May 1, 2025
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 (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 28, 2025
Last Verified
February 1, 2025
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.