AgingPhase 2NCT05001646
Electromagnetic Field Protection Device Use Impact in Healthy Volunteers
A Phase 2 study testing In-home resonance-based electromagnetic field protection device in people with Aging and Aging Well, run by TruDiagnostic.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Aging Well
- What is being tested?
- In-home resonance-based electromagnetic field protection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Annie Prestrud contact
About this study
Official title: 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.
- Conditions
- Aging, Aging Well
- Being tested
- In-home resonance-based electromagnetic field protection device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home resonance-based electromagnetic field protection deviceDevice
Participants will have an in-home EMF protection device
| Study group | Role | What they receive |
|---|---|---|
| In-home EMF protection device | Experimental | Not described Receives: Device: In-home resonance-based electromagnetic field protection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Testing
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study startMar 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Blushield USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001646
- Sponsor's protocol ID
- ALT-BS-001
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29477613Karipidis 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.
PubMed 33727687Kohli 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.
PubMed 33911261
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Impact of In-home Resonance-based Electromagnetic Field Protection Device Usage in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05001646
- Acronym / sponsor ID
- ALT-BS-001
- Conditions
- Aging, Aging Well
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Collaborators
- Blushield USA
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-home EMF protection device | Experimental | Device: In-home resonance-based electromagnetic field protection device |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-home resonance-based electromagnetic field protection deviceParticipants will have an in-home EMF protection device | Device | In-home EMF protection device |
Primary outcome
Epigenetic Testing
Time frame: Change from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Background: PubMed 29477613Hernandez-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.
- Background: PubMed 33727687Karipidis 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.
- Background: PubMed 33911261Kohli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie Prestrud contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing In-home resonance-based electromagnetic field protection device in people with Aging and Aging Well, run by TruDiagnostic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie Amalani (816-377-4651, natalie@blushield-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Testing (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05001646, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.