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| Name | Class |
|---|---|
| ANSES, France | UNKNOWN |
| INERIS, Verneuil-En-Halatte, France | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual medical Care | Other | Individual medical care in occupational and environmental diseases centers |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At 12 months after inclusion |
| Sensitivity to electromagnetic fields | At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary. | 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. | 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. | At 1 month after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life evaluation | At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36) | at 14 months. |
| Compliance to the study design | At each Visit (Day 0, Month 1, Month 6 and month 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynda BENSEFA-COLAS, MD | Service de Pathologie Professionnelle, Hopital Cochin, AP-HP, Paris | Study Director |
| Rene de SEZE, MD | INERIS (Institut National de l'EnviRonnement Industriel et des RisqueS) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre | Paris | 75014 | France |
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| Label | URL |
|---|---|
| The link presents the recruiting centers | View source |
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| Individual electromagnetic exposures | Other | 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 |
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| Sensitivity to electromagnetic fields | At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary. | at day 0 |
| Quality of life evaluation | At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36) | day 0 |