跳至主要内容
临床试验/NCT07743177
NCT07743177进行中(未招募)不适用

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

IRCCS National Neurological Institute "C. Mondino" Foundation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Differences in BAEP interpeak intervals (I-III, III-V, I-V)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Non-interpretable BAEP recordings due to lack of cooperation

结局指标

主要结局

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

时间窗: 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)

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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