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临床试验/NCT05520632
NCT05520632招募中不适用

Autism Spectrum Disorder: Brainstem Auditory Evoked Potential Findings and Behavioral Responses to Sounds

Instituto de Ciências Biomédicas Abel Salazar1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Findings in Brainstem Auditory Evoked Potentials (BAEP)

研究概览

简要总结

There are many studies in the literature that study the sensory profile of children with autism spectrum disorder (ASD), which can essentially have three types of behavior: (1) Registration, (2) Seeking, (3) Sensitivity, and (4) Avoiding. However, there are few studies dedicated to the study of the sensory profile of children with autism. A child's sensory profile is closely related to the way they deal with the world and their social interaction. The existence of tools that allow the study of the behavioral response to the sounds of children with autism spectrum disorder, will allow the application of targeted therapies in the future. Therapies targeted and adjusted to each profile observed in these children will allow to attenuate these maladjusted behavioral responses, or even overcome these deficits, if there is an early and precise intervention.

详细描述

The objectives of this work are:

PRIMARY OBJECTIVES:

  • To characterize the BAEP findings in children with ASD (case group) and compare these findings with those obtained in children matched by sex and age without suspected ASD (control group), with a special focus on the study of the following parameters:
  1. Wave I amplitude and wave V/wave I amplitude ratio (V/I ratio)
  2. Extension of the absolute latency of wave V

With the aim of:

  • Establish and describe a possible pattern in the BAEP that characterizes children with ASD
  • To characterize the subgroup of children with ASD who present alterations in the BAEP: understand if changes in BAEPs appear in children with more severe autism, if it depends on gender, if it depends on the auditory profile.
  • Characterize the Behavioral Response to Sounds of children with ASD

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Case group: children diagnosed with ASD according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorders 5th edition) and performed by a Pediatrician, Pedopsychiatry or Pediatric Neurologist; age between 3 and 6 years at the time of the audiological assessment; children with indication for BAEP; children who reveal thresholds within the normal range in the BAEP.
  • Control group: children with typical development for their age; children with indication for BAEP due to the presence of risk factors for deafness (included in the universal neonatal auditory screening program) or due to delay in language development alone requiring clarification; age between 3 and 6 years at the time of audiological examinations; children who reveal thresholds within the normal range in the BAEP.

排除标准

  • Case group: late diagnosis of ASD (> 6 years); associated pathology, such as: neurological (epilepsy, neurodegenerative disease, severe hypoxic-ischemic encephalopathy), congenital infections (TORCH group infections) with hearing impairment, chromosomal abnormalities (Down syndrome, fragile X syndrome), neurocutaneous syndromes, endocrine disorders and metabolic disorders (phenylketonuria), cleft palate or facial malformations; active ear pathology at the time of audiological evaluation (otitis media, external auditory canal infection or malformation); increase in auditory thresholds in BAEP.
  • Control group: associated pathology, such as: neurological (epilepsy, neurodegenerative disease, severe hypoxic-ischemic encephalopathy), congenital infections (TORCH group infections) with hearing loss, chromosomal abnormalities (Down syndrome, fragile X syndrome), neurocutaneous syndromes , endocrine and metabolic disorders (phenylketonuria), cleft palate or facial malformations; active ear pathology at the time of audiological evaluation (otitis media, external auditory canal infection or malformation); increase in auditory thresholds in BAEP.

结局指标

主要结局

Findings in Brainstem Auditory Evoked Potentials (BAEP)

时间窗: 3 years

Brainstem Auditory Evoked Potentials will be performed under propofol sedation. Absolute latencies (ALs) of waves I, III, and V and interpeak latencies (IPLs) I-III, III-V, and I-V were measured, as well as the amplitudes of waves I and V. These values will be compared between the group of cases (children with ASD) and controls (children without ASD). It will be evaluated whether any of these values will be persistently outside the values considered normal in children with ASD.

次要结局

  • Study of the sensory profile of children with autism spectrum disorder applying the "Child Sensory Profile 2" questionnaire(3 years)
  • Study of the auditory profile of children with autism spectrum disorder applying the"Auditory Behavior Questionnaire" questionnaire(3 years)

研究者

发起方
Instituto de Ciências Biomédicas Abel Salazar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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