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临床试验/NCT04207476
NCT04207476撤回不适用

Effects on Autonomic Nervous System Through Utilization of an Electromagnetic Resonator in Heart Failure

University of Oklahoma1 个研究点 分布在 1 个国家开始时间: 2021年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Heart rate variability(HRV)

研究概览

简要总结

To evaluate the physiologic effects of an electromagnetic resonator(EMF) on autonomic nervous system tone modulation through measurement of heart rate variability(HRV).

Null Hypothesis: An EMF Resonator will not change autonomic nervous system tone and no demonstrable difference in physiological parameters will recorded.

Alternative Hypothesis: Using an EMF Resonator will enhance parasympathetic activty as supported by HRV.

详细描述

During the initial encounter, participants will be randomized to either therapy or sham. The randomization scheme will be blinded to all investigators, will be devoid of patient information, and will be programmed by a non·investigator third party. All patients will receive the same total duration of therapy, and all patients will receive a sham and a treatment session.

Participants will wear head phones to reduce effects of any outside noises and will lay supine in a chair at approximately 40 degrees which is inside the FDA approved Resonator® EMF field. The active treatment session will be A160 which is a narrow range but variable magnetic field. This ranged from 3.1 x10·8 to 3.2 x 10-8 amplitude with a frequency of 0.857-0.859.

Eligible participants will arrive for testing in the morning and will be randomized to either treatment sequence. Randomization will be predetermined. Mobile phones and pagers will be placed into airplane mode during the study on a table in the room. The patient will be connected to HRV measurement systems. A BP reading will be taken in each arm. Patients will then lay supine in a standardized relaxation chair at approximately 40 degrees at which time the headphones will be placed. Ambient room light will remain powered on during therapy and will remain unchanged regardless of randomization. The researcher will then start either arm A or B (based on randomization). During the session, each participant will be given a short novel/magazine to read to reduce the chance of sleeping.

All HRV monitors will be disconnect and the subject's electronics will be returned.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients more than 18 years old with LVEF of < 40%(N=20)
  • Healthy age matched controls (N=20)
  • Ability to lay in a reclining chair for at least 60 minutes

排除标准

  • 1. Inability to provide consent
  • Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
  • Recent (<6 months) stroke or myocardial infarction
  • Severe heart failure (NYHA IV)
  • Hemodialysis
  • Recurrent vaso-vagal syncopal episodes
  • Unilateral or bilateral vagotomy
  • Pregnancy or breast feeding

研究组 & 干预措施

Treatment arm

Experimental

Active magnetic field exposure will be performed by use of a EMF resonator. Stimulator will be applied continuously for 1 hour.

干预措施: EMF (Device)

Placebo

Placebo Comparator

Placebo magnetic field exposure will be performed by use of a EMF resonator. Stimulator will be applied continuously for 1 hour.

干预措施: Placebo (Device)

结局指标

主要结局

Heart rate variability(HRV)

时间窗: 1 hour

HRV will be measured using continuous 10 minute ECG pre and post exposure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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