Electromagnetic Field Protection Device Use Impact in Healthy Volunteers

• Sponsor: TruDiagnostic (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05001646
• Collaborator: Blushield USA (Other)
• Enrollment: 44
• Arm: 1
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Aging Well	Device: In-home resonance-based electromagnetic field protection device	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Molecular Impact of In-home Resonance-based Electromagnetic Field Protection Device Usage in Healthy Individuals
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Epigenetic Testing [Change from baseline to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• TruDiagnostic
• Blushield USA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hernandez-Segura A, Nehme J, Demaria M. Hallmarks of Cellular Senescence. Trends Cell Biol. 2018 Jun;28(6):436-453. doi: 10.1016/j.tcb.2018.02.001. Epub 2018 Feb 21. Review.
• Karipidis K, Mate R, Urban D, Tinker R, Wood A. 5G mobile networks and health-a state-of-the-science review of the research into low-level RF fields above 6 GHz. J Expo Sci Environ Epidemiol. 2021 Jul;31(4):585-605. doi: 10.1038/s41370-021-00297-6. Epub 2021 Mar 16. Review.
• Kohli J, Wang B, Brandenburg SM, Basisty N, Evangelou K, Varela-Eirin M, Campisi J, Schilling B, Gorgoulis V, Demaria M. Algorithmic assessment of cellular senescence in experimental and clinical specimens. Nat Protoc. 2021 May;16(5):2471-2498. doi: 10.1038/s41596-021-00505-5. Epub 2021 Apr 28.

• Responsible Party: TruDiagnostic
• ClinicalTrials.gov Identifier: NCT05001646
• Other Study ID Numbers: ALT-BS-001
• First Posted: Aug 12, 2021
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 14, 2022