NCT04207476

Magnesphere for Autonomic Alteration

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DEVICE	EMF	Active magnetic field exposure will be performed by use of a EMF resonator. Stimulator will be applied continuously for 1 hour.
DEVICE	Placebo	No magnetic field exposure will be given while patients are assigned to this arm for a duration of 1 hour.

Timeline

• Start date: 2021-07-25
• Primary completion: 2022-10-12
• Completion: 2022-10-12
• First posted: 2019-12-20
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study