SpeechAV-SSR-INCT06282289
Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants
A study testing Magnetoencephalography (MEG) and Cognition development questionnaire in people with Speech, run by Institut Pasteur.
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). Read more about this study
- Who is it for?
- Ages 6 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Speech
- What is being tested?
- Magnetoencephalography (MEG) and Cognition development questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- May 2025to 21 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- A neurological disorder (visual, auditory, motor, executive)
- Developmental delay
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Speech
- Being tested
- Magnetoencephalography (MEG), Cognition development questionnaire
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetoencephalography (MEG)Behavioural
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 questionnaireOther
Computerised questionnaires completed by parents
| Study group | Role | What they receive |
|---|---|---|
| 6-month-old infants | Other | Not described Receives: Behavioral: Magnetoencephalography (MEG); Other: Cognition development questionnaire |
| 10-month-old infants | Other | Not described Receives: Behavioral: Magnetoencephalography (MEG); Other: Cognition development questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
4 experimental conditions : AV synchronous coherent, AV asynchronous coherent, AV synchronous incoherent, and AV asynchronous incoherent
Measured: at 10- and 6-months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startMay 2025 (estimated)
- Primary completion21 Sep 2025 (estimated)
- Study completion21 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpeechStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282289
- Sponsor's protocol ID
- 2023-077
- Other IDs
- 2023-A01798-37
- Acronym
- AV-SSR-I
- Status last verified
- Feb 2025
- First submitted
- 18 Dec 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants
- ClinicalTrials.gov ID
- NCT06282289
- Acronym / sponsor ID
- AV-SSR-I / 2023-077
- Conditions
- Speech
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Study start
- May 2025 (estimated)
- Primary completion
- 21 Sep 2025 (estimated)
- Study completion
- 21 Sep 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-month-old infants | Other | Behavioral: Magnetoencephalography (MEG), Other: Cognition development questionnaire |
| 10-month-old infants | Other | Behavioral: Magnetoencephalography (MEG), Other: Cognition development questionnaire |
Who may qualify
- Ages
- 6 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- A neurological disorder (visual, auditory, motor, executive)
- Developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 10-month-old infants, 6-month-old infants |
| Cognition development questionnaireComputerised questionnaires completed by parents | Other | 10-month-old infants, 6-month-old infants |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetoencephalography (MEG) and Cognition development questionnaire in people with Speech, run by Institut Pasteur.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Bouton, PhD (0176535072 ext. +33, sophie.bouton@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.