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临床试验/NCT02878824
NCT02878824已完成不适用

Role of Ethnicity and Environment on Regulation of Response Towards Sensory Stimulation in Children: A Neurophysiological Study

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
1
主要终点
Heart Rate Variability

研究概览

简要总结

Difference in autonomic nervous system processes across cultural and ethnic groups was suggested and autonomic regulation differentiation may occur even at an early age. However, the role of ethnicity and environment on regulation of response towards sensory stimulation in children is not well understood yet. This research aims to compare the autonomic activity at resting condition and toward a block of auditory stimulation between typically developing children from different countries and living environments. There will be two phases in this study. In Phase I, two groups of participants will be recruited: (a) 32 typically-developing Chinese children living in Hong Kong, (HK group) and (b) 32 typically developing Filipino children living in Hong Kong (Fil-HK group). In phase II, two groups of participants will be recruited: (a) 32 typically-developing Filipino children who are living at Urban area (PH-U group), and (b) 32 typically developing Filipino children who are living at Philippines-Rural area (PH-R group). Participants will be composed of males and females ages 7-12 years old, and without known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits. Recruited participants will watch a silent movie, and listen to a block of sound. Autonomic activity (heart rate variability and electrodermal activity) will be measured and recorded using Polar H2 heart rate monitor and eSense skin response. Recordings will be screened for ectopic beats of HRV or bursts of EDA. The HRV and EDA signals will be processed by using aHRV and the eSense propriety software, respectively, and according to the standards of editing HRV and EDA artefacts. Autonomic activity (LF, HF and EDA) at resting condition, and hypothesis interaction between conditions (resting condition vs. auditory stimulation) and groups (HK group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group) will be tested with repeated measures of MANOVA. All significant levels will be set at p≤ 0.05. This study will increase the understanding on the role of culture and environment in the regulation of behaviour in auditory processing. The findings of this research may further shed light on the evaluation and treatment planning for children across and within cultures.

详细描述

Background: Difference in autonomic nervous system (ANS) processes across cultural and ethnic groups was suggested and autonomic regulation differentiation may occur even at an early age. However, the role of ethnicity and environment on regulation of response towards sensory stimulation in children is not well understood yet. This research aims to compare the autonomic activity at resting condition and toward a block of auditory stimulation between typically developing children from different countries and living environments and examine the role of environments and ethnicity on autonomic regulation.

Methods: Four groups of typically-developing participants will be recruited in this study: 1) Chinese children living in Hong Kong (n=32); Filipino children living in Hong Kong (32); Filipino children living in urban-Philippines (n=32); Filipino children living in urban-Philippines (n=32). Participants will be males (nm=16) and females (nf=16), ages 7-12 years old, and without known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits. Recruited participants will watch a silent movie, and listen to a block of sound stimulus presentations. Autonomic activity (heart rate variability and electrodermal activity) will be measured and recorded using Polar H2 heart rate monitor and eSense GSR. Recordings will be screened for ectopic beats of HRV or bursts of EDA. The HRV and EDA signals will be processed by using aHRV and Ledalab software, respectively, and according to the standards of editing and analysing HRV and EDA artefacts. Autonomic activity (LF, HF and EDA) at experimental condition groups (HK group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group) will be tested with repeated measures of MANOVA. All significant levels will be set at a critical α=> .05.

Discussion: This study will increase the understanding on the role of culture and environment in the regulation of behaviour in auditory processing. The findings of this research may further shed light on the evaluation and treatment planning for children across and within cultures.

研究设计

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

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • male or female
  • 7-12 years old
  • enrolled in primary school
  • currently resides in the country/area in context
  • for Hong Kong participants: Hong Kong-Chinese national
  • for Philippine participants: born and living within the area in context

排除标准

  • known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits
  • repeated a grade level
  • multiracial parental background

结局指标

主要结局

Heart Rate Variability

时间窗: Day 1

Heart rate variability (HRV) has been considered as a promising marker for autonomic activity, specifically of parasympathetic nervous system (PNS) activity (Task Force of the European Society of Cardiology and the North American Society for Pacing and Electrophysiology, 1996). Frequency domain analysis covers total power (0.0-0.5 Hz) in its raw and normalized units, low (LF; 0.04-0.15 Hz) and high (HF; 0.15-0.40 Hz) frequency components in its raw and normalized units. The normalized units of the LF will be used as representative of predominantly sympathetic modulation activity (SNS), while the normalized units of the HF will be used as representatives of parasympathetic modulation activity. Since HRV can measure both SNS and PNS simultaneously, this study will use HRV as one of the measurements. Nevertheless, it has been argued if the value of LF is a pure measure of SNS (Goldstein et al., 2011). Therefore, other than HRV, EDA will also be a supplementary measurement.

Electrodermal Activity

时间窗: Day 1

Electrodermal activity (EDA) is a valid measure of autonomic nervous system activity frequently used to index behavioural processes (Boucsein, Fowles, Grimnes, Ben-Shakhar \& Roth, 2012). EDA is composed of a tonic and phasic drivers that reflect autonomic availability and response patterns respectively. Tonic EDA will be represented by the CDA.Tonic, which has been recommended to be the most accurate representation of the deconvoluted underlying skin conductance level within the specified block expressed in µS (Benedek \& Kaernbach, 2010). To represent the sympathetic activity in the form of phasic skin conductance response, the CDA.SCR will computed. The CDA.SCR is considered as the average phasic driver within the specified response window initially set, and represents the phasic EDA most accurately expressed in units of µS (Benedek \& Kaernbach, 2010).

次要结局

  • Temperament: English and Chinese versions of the Temperament in Middle Child Questionnaire and Early Adolescent Temperament Questionnaire(Day 1)
  • Resilience: English and Chinese versions of the Child and Youth Resilience Measure(Day1)
  • Sensory Behaviours: English and Chinese versions of the Sensory Profile(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GOMEZ Ivan Neil Benitez

Mr.

The Hong Kong Polytechnic University

研究点 (1)

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