NCT06178276

Brief Summary

The oral comprehension (OC) of a second language (L2) involves different cognitive processes, specially during the learning phase. This study aims at investigating the neurophysiological functioning of different steps involved in this oral understanding.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 14, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

November 16, 2023

Last Update Submit

February 15, 2024

Conditions

LearningLanguageComprehension

Keywords

Language LearningOral comprehensionautonomic activitybrain activity

Outcome Measures

Primary Outcomes (1)

  • Sympathetic activity

    ElectroDermal Activity (EDA) measured in µS

    up to 3 months following the language profile completion

Secondary Outcomes (8)

  • Parasympathetic activity

    up to 3 months following the language profile completion

  • Activated brain regions demonstrating brain activity

    up to 6 months following the language profile completion

  • Correlations between sympathetic and parasympathetic activity

    up to 3 months following the language profile completion

  • Interaction between sympathetic activity and brain activity

    up to 6 months following the acquisition of language profile

  • Interaction between parasympathetic activity and brain activity

    up to 6 months following the acquisition of language profile

  • +3 more secondary outcomes

Study Arms (2)

A2 level

Level of oral comprehension in italian language

Diagnostic Test: behaviorDiagnostic Test: physiologyDiagnostic Test: imaging

B2 level

Level of oral comprehension in italian language

Diagnostic Test: behaviorDiagnostic Test: physiologyDiagnostic Test: imaging

Interventions

behaviorDIAGNOSTIC_TEST

behavioral measurements will be performed during the oral comprehension testing

A2 levelB2 level
physiologyDIAGNOSTIC_TEST

physiologic (autonomic) measurements will be performed during the oral comprehension testing

Also known as: autonomic
A2 levelB2 level
imagingDIAGNOSTIC_TEST

central (brain) measurements will be performed during the oral comprehension testing

Also known as: fMRI
A2 levelB2 level

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

French learner in Italian language recruited at university

You may qualify if:

  • French learner in Italian language
  • right-handed
  • affiliated to French social security
  • informed consent signed

You may not qualify if:

  • pregnant woman
  • audiologic pathology impacting the capacity of hearing
  • neurologic or psychiatric pathology that may interfere with oral comprehension
  • learning disability (for instance: dyslexia)
  • contra-indication to MRI and to EDA acquisition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38700, France

RECRUITING

MeSH Terms

Conditions

Language

Interventions

Microbial InteractionsDiagnostic ImagingMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

CommunicationBehavior

Intervention Hierarchy (Ancestors)

Microbiological PhenomenaDiagnostic Techniques and ProceduresDiagnosisTomography

Study Officials

  • Triscia Biagiotti, Ms

    University Grenoble Alpes

    STUDY CHAIR

Central Study Contacts

Chantal M Delon-Martin, PhD

CONTACT

+33 4 56 52 05 89chantal.delon@univ-grenoble-alpes.fr

Monica Masperi, PhD

CONTACT

+33 4 76 82 77 48monica.masperi@univ-grenoble-alpes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

December 20, 2023

Study Start

February 14, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

FR(1)