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临床试验/NCT02768636
NCT02768636已完成4 期

Can Omega-3 Improve Heart Rate Variability Measurement?

Vachira Phuket Hospital4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
4
主要终点
Change in Heart Rate Variability assessed using the SA-3000P

研究概览

简要总结

Heart rate variability can represent physiological and psychological levels via sympathetic and parasympathetic variables on autonomic nervous function. Omega-3 has shown that it can effect on physiological and psychological with many good results. The pathways to explain about its effect had been studied in many contexts. Effect to autonomic nervous function by Omega-3 is our interesting question.

详细描述

Heart Rate Variability (HRV). HRV has two domains, time domain and frequency domain. SDNN (Standard Deviation Normal to Normal) is the first time domain. In healthy state, the signal is more diversity and SDNN is high. Decrease of SDNN means that ability to maintain homeostasis is reduced. It is shown while a person is in any disease state. Significant decreasing of HRV is an indicator for general health. PSI (Physical Stress Index) is the pressure loaded state due to overloaded physical activity and heart rate is increasing. Total power (TP), Very low frequency (VLF), Low frequency (LF), High frequency (HF), normalized Low frequency (nLF, LF norm) = LF/(LF +HF), normalized High frequency (nHF, HF norm) = HF/(LF+HF) and Low frequency to High frequency ratio (LF/HF) are frequency domain. Mean Heart rate (MHR) is also an indicator representing autonomic function.

Range of study: It will be done during April - May 2016.

Population Enrollment and recruitment was done by selected volunteers for our 100 participants.

Investigator: Training investigators were selected from psychologists, technicians, nurses, medical students and hospital health colleagues. Certified attending the class of training, assessment and evaluation was done before study.

Maneuver: Instruments were questionnaires and HRV measurements by SA-3000P. Fast Fourier Transformation method (FFT) was applied underlying it. Finger probe was used by five minutes with comfort sitting upright position. Normal respiration and not heavy pay attention in the monitor by looking to the wall. Enough sleeping in the night before study and no take coffee, drugs, alcohol or smoking two hours before study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged group is 18-65 years old
  • Understanding communication
  • Normal electrocardiogram
  • Allowance by their physicians
  • No disturbance with their regular treatments

排除标准

  • Abnormal bleeding tendency problems
  • Non-understanding communication
  • No enough time persons
  • No information allowance
  • Complicated illnesses conditions

结局指标

主要结局

Change in Heart Rate Variability assessed using the SA-3000P

时间窗: Baseline and 30 days

Comparative participants' Heart rate variability study will be done before and after 30 days treated with Omega-3. Instruments were questionnaires and HRV measurements by SA-3000P. Fast Fourier Transformation method (FFT) was applied underlying it. Finger probe was used by five minutes with comfort sitting upright position. Variables: HRT (BPM), Heart rate; SDNN (ms), Standard deviation of normal to normal interval; RMSSD (ms), the square root of the mean squared differences of successive NN intervals; PSI (No scale), Physical stress index; ApEn (No scale), Approximate Entropy; SRD (No scale), Successive R-R interval difference; TSRD (No scale), Total SRD; TP (ms\^2), Total power; VLF (ms\^2), Very low frequency; LF (ms\^2), Low frequency; HF (ms\^2), High frequency; nLF (n.u.), normalized LF; nHF (n.u.), normalized HF, LF/HF, Low frequency/ High frequency

次要结局

未报告次要终点

研究者

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

Jessada Chungpaibulpatana, Tappana Sumpatanarax

Director, Principal investigator; Co-investigator

Vachira Phuket Hospital

研究点 (4)

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