🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Italy / NCT07531706
Recruiting Observational

Cortical Tracking of Speech in the First Year of Life

NCT07531706 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-10-14
Last updated
2026-04-15

Condition(s) studied

Language DevelopmentLanguage Development DisordersInfant DevelopmentInfant Developmental Assessment

Investigational drug(s) / intervention(s)

Electrophysiological recordingBehavioral Assessment

Electrophysiological recording: Investigation of early neural markers using electrophysiology at 8 months

Behavioral Assessment: Behavioral Assessment at 8 months with Bayley-III Scales of Infant and Toddler Development.

Study summary

The goal of this observational study is to investigate early neural mechanisms underlying the processing of spoken language, specifically the phenomenon of cortical tracking, and to determine whether these mechanisms can serve as early predictors of later language development outcomes in infants, including both typical and atypical trajectories.

The main questions it aims to answer are:

* How do infants with and without a familial history of language and learning impairments differ in their neural ability to track speech and non-speech auditory stimuli at an early stage of development (around 8 months of age)?
* To what extent do early cortical tracking mechanisms predict later language abilities, including both receptive and expressive skills, measured at approximately 18 months of age? Researchers will compare infants with a familial risk for language and learning impairments (FH+) to infants without such risk (FH-) to determine whether differences in early neural processing of auditory stimuli are associated with later language outcomes.

Participants will:

* undergo a neurophysiological assessment involving non-invasive electroencephalographic (EEG) recording while being exposed to auditory stimuli, including: speech stimuli (pre-recorded simple stories in Italian, presented in infant-directed speech); non-speech stimuli (musical sounds matched for rhythmic and acoustic properties)
* take part in a developmental assessment at approximately 8 months of age, including standardized measures of cognitive and early linguistic abilities
* be involved in a follow-up assessment approximately 10 months later (around 18 months of age), during which standardized tests will evaluate language comprehension and production abilities
* have additional background information collected, including family history of language and learning disorders and socio-demographic characteristics, to better understand potential risk and protective factors The study follows a longitudinal design and uses non-invasive procedures that do not require active responses from the infant.

Eligibility

Sex
ALL
Min age
30 Weeks
Max age
34 Weeks
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy infants aged between 7 and 8 months * Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders). * Both parents are native-Italian speakers Exclusion Criteria: * Gestational age \< 37 weeks and/or birth-weight \< 2500 grams * APGAR scores at birth at 1' and 5' \< 7 * Bayley Cognitive Score \< 7 * Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Eugenio Medea Associazione La nostra famiglia Bosisio Parini Lecco Recruiting

More IRCCS Eugenio Medea trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07531706 on ClinicalTrials.gov ↗ ← All trials in Italy