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

NCT ID: NCT06282289

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2025-09-21

Brief Summary

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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.

Detailed Description

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Conditions

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Speech

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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6-month-old infants

Group Type OTHER

Magnetoencephalography (MEG)

Intervention Type BEHAVIORAL

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.

Cognition development questionnaire

Intervention Type OTHER

Computerised questionnaires completed by parents

10-month-old infants

Group Type OTHER

Magnetoencephalography (MEG)

Intervention Type BEHAVIORAL

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.

Cognition development questionnaire

Intervention Type OTHER

Computerised questionnaires completed by parents

Interventions

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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.

Intervention Type BEHAVIORAL

Cognition development questionnaire

Computerised questionnaires completed by parents

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

10 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de l'Audition

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sophie Bouton, PhD

Role: CONTACT

0176535072 ext. +33

Anne-Lise Giraud, PhD

Role: CONTACT

0176535054 ext. +33

Other Identifiers

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2023-A01798-37

Identifier Type: OTHER

Identifier Source: secondary_id

2023-077

Identifier Type: -

Identifier Source: org_study_id

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