Electromagnetic Field Protection Device Use Impact in Healthy Volunteers

March 10, 2022 updated by: TruDiagnostic

Clinical and Molecular Impact of In-home Resonance-based Electromagnetic Field Protection Device Usage in Healthy Individuals

This is a prospective, single group, self-controlled study to evaluate the clinical and molecular impact of continuous in-home resonance-based electromagnetic field (EMF) protection device usage in healthy individuals.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any sex, gender orientation, and ethnicity
  • Between ages 30 and 70
  • Must be willing and able to participate in venipuncture, health history and clinical assessments, passive monitoring (Oura ring), and continuous in-home Blushield device usage

Exclusion Criteria:

  • Significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition 2. Any ongoing immune system concerns or immunodeficiency disease
  • History of any viral illness in preceding year
  • Body mass index (BMI) > 35 kg/m2
  • Presence of active infection
  • Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable
  • Unable or unwilling to provide required biological sample
  • Unable or unwilling to avoid pregnancy during study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: In-home EMF protection device
Device: In-home resonance-based electromagnetic field protection device
Participants will have an in-home EMF protection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epigenetic Testing
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TruDiagnostic

Collaborators

Blushield USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (ACTUAL)

August 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ALT-BS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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