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Clinical Trials/NCT07743177
NCT07743177Active, not recruitingNot Applicable

Auditory Brainstem Evoked Potentials in Autism Spectrum Disorder: A Window on Neural Maturation and Sex Differences

IRCCS National Neurological Institute "C. Mondino" Foundation1 site in 1 country200 target enrollmentStarted: March 31, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
200
Locations
1
Primary Endpoint
Differences in BAEP interpeak intervals (I-III, III-V, I-V)

Study Overview

Brief Summary

This retrospective study investigates auditory brainstem evoked potentials (BAEPs) in children with autism spectrum disorder (ASD) compared with other neuropsychiatric conditions. The study aims to evaluate differences in BAEP parameters, with particular attention to sex- and age-related effects and clinical severity

Detailed Description

Autism spectrum disorder is a neurodevelopmental condition frequently associated with atypical sensory processing, particularly in the auditory domain. BAEPs provide an objective neurophysiological measure of auditory pathway integrity and maturation at the brainstem level.

This study retrospectively analyzes BAEP recordings collected at IRCCS Fondazione Mondino between January 2021 and December 2023. Latencies of waves I, III, and V, as well as interpeak intervals (I-III, III-V, I-V), are compared between children with ASD and children with other neuropsychiatric conditions.

Secondary analyses explore associations between BAEP parameters, ASD severity, age, and sex, in order to clarify potential neurobiological differences and evaluate BAEPs as candidate electrophysiological biomarkers for ASD.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
2 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Children aged 2-5 years
  • BAEP examination performed at IRCCS Fondazione Mondino between January 2021 and December 2023
  • Diagnosis/Suspicion of autism spectrum disorder or other neuropsychiatric conditions
  • Availability of technically reliable BAEP recordings

Exclusion Criteria

  • Non-interpretable BAEP recordings due to lack of cooperation

Outcomes

Primary Outcomes

Differences in BAEP interpeak intervals (I-III, III-V, I-V)

Time Frame: Single assessment at admission between 2021 and 2023 (retrospective analysis)

Differences in BAEP interpeak intervals (I-III, III-V, I-V) between children with ASD and other neuropsychiatric conditions

Differences in BAEP wave latencies (I, III, V)

Time Frame: Single assessment at admission between 2021 and 2023 (retrospective analysis)

Differences in BAEP wave latencies (I, III, V) and interpeak intervals (I-III, III-V, I-V) between children with ASD and other neuropsychiatric conditions

Secondary Outcomes

  • BAEP parameters and ASD severity(Single assessment at admission between 2021 and 2023 (retrospective analysis))
  • BAEP parameters and age(Single assessment at admission between 2021 and 2023 (retrospective analysis))
  • BAEP parameters and sex(Single assessment at admission between 2021 and 2023 (retrospective analysis))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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