Magnesphere for Autonomic Alteration

Hart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04207476
• Other study ID #: 11415
• Status: Withdrawn
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: October 12, 2022

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hart Failure With Reduced Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability(HRV)	HRV will be measured using continuous 10 minute ECG pre and post exposure	1 hour