Electromagnetic FieldIEI CEM EN MEDNCT06556901
Management of Patients Who Claim to be Electrosensitive
An observational study of Electromagnetic Field, run by University Hospital, Brest at 1 site in France.
Trial summary
Know qualitatively the ways to deal with these patients, in general medicine in Brittany, and the difficulties encountered, through thematic and lexicometric analysis of responses Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Electromagnetic Field
- What is being tested?
- retrospective study about reasons for consultations
- How many people
- 1,400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Sep 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Population of general practitioners practicing in Brittany in 2018. Population assessed by the ODM between 3000 and 3200 liberal general practitioners
Who may be able to join
None listed.
Who cannot join
- be other practionners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Feeling of General Practitioners in the Management of Patients Who Claim to be Electrosensitive
Know qualitatively the ways to deal with these patients, in general medicine in Brittany, and the difficulties encountered, through thematic and lexicometric analysis of responses
Read the detailed description
The Ministry of Health instructed the French society of medicine work (Dr Pougnet for the Brest CHRU) to coordinate the drafting of practical guides for the management of people claiming to have IEI-CEM (Intolerance Environmental Idiopathic in the Fields ElectroMagnetic) for care physicians primary (general practitioners). To meet this mission, it is necessary to know qualitatively the difficulties encountered by general practitioners during the management of these people.
- Conditions
- Electromagnetic Field
- Being tested
- retrospective study about reasons for consultations
- Keywords
- qualitative study, environmental exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective study about reasons for consultationsOther
retrospective study about reasons for consultations
What is being measured
The primary outcome is the main question the study is designed to answer.
principal
The main endpoint is to have taken care of a patient who claims to have electromagnetic sensibility.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electromagnetic FieldStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556901
- Sponsor's protocol ID
- 29BRC19.0155
- Acronym
- IEI CEM EN MED
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanderstraeten J, Verschaeve L. Biological effects of radiofrequency fields: Testing a paradigm shift in dosimetry. Environ Res. 2020 May;184:109387. doi: 10.1016/j.envres.2020.109387. Epub 2020 Mar 12.
PubMed 32182484
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feeling of General Practitioners in the Management of Patients Who Claim to be Electrosensitive
- ClinicalTrials.gov ID
- NCT06556901
- Acronym / sponsor ID
- IEI CEM EN MED / 29BRC19.0155
- Conditions
- Electromagnetic Field
- Keywords
- qualitative study, environmental exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 16 Aug 2024 (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.
Know qualitatively the ways to deal with these patients, in general medicine in Brittany, and the difficulties encountered, through thematic and lexicometric analysis of responses
Detailed description
The Ministry of Health instructed the French society of medicine work (Dr Pougnet for the Brest CHRU) to coordinate the drafting of practical guides for the management of people claiming to have IEI-CEM (Intolerance Environmental Idiopathic in the Fields ElectroMagnetic) for care physicians primary (general practitioners). To meet this mission, it is necessary to know qualitatively the difficulties encountered by general practitioners during the management of these people.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population of general practitioners practicing in Brittany in 2018. Population assessed by the ODM between 3000 and 3200 liberal general practitioners
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- be other practionners
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 |
|---|---|---|
| retrospective study about reasons for consultationsretrospective study about reasons for consultations | Other | – |
Primary outcome
principal
Time frame: 2 years
The main endpoint is to have taken care of a patient who claims to have electromagnetic sensibility.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 32182484Vanderstraeten J, Verschaeve L. Biological effects of radiofrequency fields: Testing a paradigm shift in dosimetry. Environ Res. 2020 May;184:109387. doi: 10.1016/j.envres.2020.109387. Epub 2020 Mar 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electromagnetic Field, run by University Hospital, Brest at 1 site in France.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
principal (time frame: 2 years). 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 NCT06556901, which also lists 1 linked publication.
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 16 Aug 2024.