Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

Conditions
-----------------
Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

Intervention / Treatment
-----------------
* Other: Individual medical Care
* Other: Individual electromagnetic exposures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Other: Individual medical Care<br>* Individual medical care in occupational and environmental diseases centers<br>Other: Individual electromagnetic exposures<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 
| Sensitivity to electromagnetic fields | At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary. | at day 0 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| Quality of life evaluation | At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36) | day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EHS, IEI-EMF, Radiofrequency, WI-FI, DECT, Electro-sensitivity, Idiopathic, Environmental, Intolerance fields, Mobile phone