Magnesphere for Autonomic Alteration

N/AWithdrawnNCT04207476

University of Oklahoma

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Hart Failure With Reduced Ejection Fraction

Interventions

EMFDEVICE

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

PlaceboDEVICE

No magnetic field exposure will be given while patients are assigned to this arm for a duration of 1 hour.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female patients more than 18 years old with LVEF of \< 40%(N=20) 2. Healthy age matched controls (N=20) 3. Ability to lay in a reclining chair for at least 60 minutes Exclusion Criteria: * 1\. Inability to provide consent 2. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases) 3. Recent (\<6 months) stroke or myocardial infarction 4. Severe heart failure (NYHA IV) 5. Hemodialysis 6. Recurrent vaso-vagal syncopal episodes 7. Unilateral or bilateral vagotomy 8. Pregnancy or breast feeding

Locations (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Heart rate variability(HRV)

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

Time frame: 1 hour

Data from ClinicalTrials.gov

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