Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants
AV-SSR-I
2 other identifiers
interventional
64
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2025
CompletedMarch 3, 2025
February 1, 2025
5 months
December 18, 2023
February 28, 2025
Conditions
Outcome Measures
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.
at 10-months, 6-months and 18-months of age
Secondary Outcomes (2)
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
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
at 10- and 6-months of age
Study Arms (2)
6-month-old infants
OTHER10-month-old infants
OTHERInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- A neurological disorder (visual, auditory, motor, executive)
- Developmental delay
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
- Institut de l'Auditioncollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2023
First Posted
February 28, 2024
Study Start
May 1, 2025
Primary Completion
September 21, 2025
Study Completion
September 21, 2025
Last Updated
March 3, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share