NCT05001646

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

July 27, 2021

Last Update Submit

March 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Epigenetic Testing

    Change from baseline to 12 weeks

Study Arms (1)

In-home EMF protection device

EXPERIMENTAL
Device: In-home resonance-based electromagnetic field protection device

Interventions

Participants will have an in-home EMF protection device

In-home EMF protection device

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29477613BACKGROUND
  • 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.

    PMID: 33727687BACKGROUND
  • 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.

    PMID: 33911261BACKGROUND

Central Study Contacts

Annie Prestrud

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 12, 2021

Study Start

March 1, 2022

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

March 14, 2022

Record last verified: 2022-03