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临床试验/NCT02997566
NCT02997566已完成不适用

Autonomic Modulation and Facial Expression in Autism Spectrum Disorder: Cross-sectional Study

Universidade Estadual Paulista Júlio de Mesquita Filho1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Autonomic evaluation

研究概览

简要总结

Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the better will be the prognosis. In this context, heart rate variability (HRV) stands out, which is a non-invasive tool representing autonomic modulation, with potential prognostic value. The literature showed there are no changes in HRV at rest using linear methods of analysis, but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and provide additional information to the linear. Objective: to analyze autonomic modulation using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in comparison to typical children. In addition, to correlate HRV analysis between them, also between behavior and severity of the disease. Methods: this study involves both typical children and children with ASD. Autonomic modulation will be performed using nonlinear indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to identify differences between moments and protocols two-way analysis of variance will be used along with the Bonferroni post-test or Dunn post-test according to the data distribution. Statistical significance will be set at 5%.

研究设计

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

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with autistic disorder or typical development.

排除标准

  • Participants that do not participant of all evaluations.
  • Participants with an error superior to 5% in the RR intervals series.

结局指标

主要结局

Autonomic evaluation

时间窗: June, 2017

Heart rate variability at rest, during facial expression games and finish at rest.

次要结局

  • Childhood Autism Rating Scale (CARS)(June, 2017)
  • Autistic Behavior Checklist(June, 2017)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Carlos Marques Vanderlei

PhD

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (1)

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