Idiopathic Environmental Intolerance Attributed to Electromagnetic FieldsIEI-CEMNCT01854801
Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields
A study testing Individual medical Care and Individual electromagnetic exposures in people with Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
- What is being tested?
- Individual medical Care and Individual electromagnetic exposures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2012to 30 Apr 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who declare themselves to be intolerant to electromagnetic fields
- Subjects over 18 years old
- Subjects affiliated to a social security scheme
- Subjects who signed the consent form
Who cannot join
- Subject with a disorder of the understanding of the French language at the discretion of the investigator
- Pregnant women,
- Persons deprived of their liberty, persons under guardianship, and persons in emergency situations.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre
Paris, 75014
About this study
Official title: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.
Read the detailed description
110 patients suffering from Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) are expected in this trial.
Type of trial: Interventional multicenter study, non-randomized, with measurement before and after intervention. Each patient is his own control.
Primary outcome: Efficacy of an individual medical care on electro sensitive (IEI CEM) patients evaluated from the improvement of health status, sensitivity to electromagnetic fields (EMF) exposure, and quality of life.
Scheme:
Visit 1(T0): Patients undergo a specialized medical examination: a standardized medical record is filled in. Physicians evaluate the psychological impact of IEI-EMF and a psychotherapeutic care is proposed if necessary. Patients fill in 2 self-questionaries: quality of life (SF-36) and EMF exposure sensitivity.
After the visit 1, a symptoms self-administrated questionary n°1 is completed during 7 days.
1 month after inclusions (T1), radiofrequencies (RF) are recorded by a dosimeter worn by patients for 7 days; patient fill-in the symptoms self-administrated questionary n° 2 during the same time.
Visit 2: 6 months after inclusion, analysis of symptoms and RF exposure is restituted at patient. An adapted care is proposed.
12 months after inclusion (T12), patients complete the symptoms self-administrated questionary n°3.
Visit 3: 14 months after inclusion (T14), patients have medical examination and complete the quality of life and EMF exposure sensitivity self-questionaries. Standardized medical record is filled in by physicians. Patient and physician discuss the global and comparative analysis of individual results.
Inclusion duration: 24 month; Follow-up: 14 months; Study duration: 38 months.
- Being tested
- Individual medical Care, Individual electromagnetic exposures
- Keywords
- IEI-EMF, WI-FI, DECT, Electro-sensitivity, Radiofrequency, EHS, Idiopathic, Environmental, Intolerance fields, Mobile phone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual medical CareOther
Individual medical care in occupational and environmental diseases centers
Individual electromagnetic exposuresOther
During 7 days, patient hold a dosimeter measuring their electromagnetic exposures for FM, TV, GSM, DECT, WIFI, TETRA and relay antenna emissions. During this week, patients notify intensity and time of their symptoms on a self-questionary
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients who declare themselves to be intolerant to electromagnetic fields benefit from medical care in occupational and environmental diseases centers and from a measurement of individual electromagnetic exposures and symptoms episodes. Each patient is his own control. Receives: Other: Individual medical Care; Other: Individual electromagnetic exposures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of symptoms severity
At month 12 months the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
Measured: At 12 months after inclusion .
Measurement of symptoms frequency
At month 12 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
Measured: At 12 months after inclusion
Sensitivity to electromagnetic fields
At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.
Measured: at 14 months
Measurement of symptoms frequency
At month 1 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
Measured: At 1 month after inclusion
Measurement of symptoms severity
At month 1 month the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
Measured: At 1 month after inclusion
Sensitivity to electromagnetic fields
At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.
Measured: at day 0
Secondary outcomes (3)
Quality of life evaluation
At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36)
Measured: at 14 months.
Compliance to the study design
Measured: At each Visit (Day 0, Month 1, Month 6 and month 14)
Quality of life evaluation
At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study start9 Mar 2012
- Primary completion30 May 2015
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Environmental Intolerance Attributed to Electromagnetic FieldsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ANSES, France, INERIS, Verneuil-En-Halatte, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Lynda BENSEFA-COLAS, MD, Study director, Service de Pathologie Professionnelle, Hopital Cochin, AP-HP, ParisRene de SEZE, MD, Study director, INERIS (Institut National de l'EnviRonnement Industriel et des RisqueS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854801
- Sponsor's protocol ID
- P100120
- Acronym
- IEI-CEM
- Status last verified
- Oct 2025
- First submitted
- 24 Apr 2013
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
- ClinicalTrials.gov ID
- NCT01854801
- Acronym / sponsor ID
- IEI-CEM / P100120
- Keywords
- IEI-EMF, WI-FI, DECT, Electro-sensitivity, Radiofrequency, EHS, Idiopathic, Environmental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ANSES, France, INERIS, Verneuil-En-Halatte, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Mar 2012 (actual)
- Primary completion
- 30 May 2015 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 16 May 2013 (estimated)
- 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.
The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.
Detailed description
110 patients suffering from Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) are expected in this trial.
Type of trial: Interventional multicenter study, non-randomized, with measurement before and after intervention. Each patient is his own control.
Primary outcome: Efficacy of an individual medical care on electro sensitive (IEI CEM) patients evaluated from the improvement of health status, sensitivity to electromagnetic fields (EMF) exposure, and quality of life.
Scheme:
Visit 1(T0): Patients undergo a specialized medical examination: a standardized medical record is filled in. Physicians evaluate the psychological impact of IEI-EMF and a psychotherapeutic care is proposed if necessary. Patients fill in 2 self-questionaries: quality of life (SF-36) and EMF exposure sensitivity.
After the visit 1, a symptoms self-administrated questionary n°1 is completed during 7 days.
1 month after inclusions (T1), radiofrequencies (RF) are recorded by a dosimeter worn by patients for 7 days; patient fill-in the symptoms self-administrated questionary n° 2 during the same time.
Visit 2: 6 months after inclusion, analysis of symptoms and RF exposure is restituted at patient. An adapted care is proposed.
12 months after inclusion (T12), patients complete the symptoms self-administrated questionary n°3.
Visit 3: 14 months after inclusion (T14), patients have medical examination and complete the quality of life and EMF exposure sensitivity self-questionaries. Standardized medical record is filled in by physicians. Patient and physician discuss the global and comparative analysis of individual results.
Inclusion duration: 24 month; Follow-up: 14 months; Study duration: 38 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Individual medical Care, Other: Individual electromagnetic exposuresPatients who declare themselves to be intolerant to electromagnetic fields benefit from medical care in occupational and environmental diseases centers and from a measurement of individual electromagnetic exposures and symptoms episodes. Each patient is his own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who declare themselves to be intolerant to electromagnetic fields
- Subjects over 18 years old
- Subjects affiliated to a social security scheme
- Subjects who signed the consent form
Key exclusion criteria (3 listed)
- Subject with a disorder of the understanding of the French language at the discretion of the investigator
- Pregnant women,
- Persons deprived of their liberty, persons under guardianship, and persons in emergency situations.
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 |
|---|---|---|
| Individual medical CareIndividual medical care in occupational and environmental diseases centers | Other | Experimental |
| Individual electromagnetic exposuresDuring 7 days, patient hold a dosimeter measuring their electromagnetic exposures for FM, TV, GSM, DECT, WIFI, TETRA and relay antenna emissions. During this week, patients notify intensity and time of their symptoms on a self-questionary | Other | Experimental |
Primary outcome
Measurement of symptoms severity
Time frame: At 12 months after inclusion .
At month 12 months the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
Measurement of symptoms frequency
Time frame: At 12 months after inclusion
At month 12 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
Sensitivity to electromagnetic fields
Time frame: at 14 months
At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.
Measurement of symptoms frequency
Time frame: At 1 month after inclusion
At month 1 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
Measurement of symptoms severity
Time frame: At 1 month after inclusion
At month 1 month the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
Sensitivity to electromagnetic fields
Time frame: at day 0
At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.
3 secondary outcomes
Quality of life evaluation
Time frame: at 14 months.
Compliance to the study design
Time frame: At each Visit (Day 0, Month 1, Month 6 and month 14)
Quality of life evaluation
Time frame: day 0
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 20 Nov 2025.
- The link presents the recruiting centersLink provided by the sponsor.
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.
Lynda BENSEFA-COLAS, MD study director
Service de Pathologie Professionnelle, Hopital Cochin, AP-HP, Paris
Rene de SEZE, MD study director
INERIS (Institut National de l'EnviRonnement Industriel et des RisqueS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual medical Care and Individual electromagnetic exposures in people with Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 3 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 20 Nov 2025. 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?
Measurement of symptoms severity (time frame: At 12 months after inclusion .). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.