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NCT Number: NCT07743177

Auditory Brainstem Evoked Potentials in Autism Spectrum Disorder

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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Translational Neurophysiology

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  1. BAEP parameters and ASD severity

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

    Correlation between BAEP parameters and ASD severity

  2. BAEP parameters and age

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

    Correlation between BAEP parameters and age

  3. BAEP parameters and sex

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

    Correlation between BAEP parameters and sex

Sponsors and collaborators

Lead sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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