Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Conditions
Keywords
IEI-EMF, WI-FI, DECT, Electro-sensitivity, Radiofrequency, EHS, Idiopathic, Environmental, Intolerance fields, Mobile phone
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.
Interventions
OTHERIndividual medical Care
Individual medical care in occupational and environmental diseases centers
OTHERIndividual electromagnetic exposures
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
Sponsors
ANSES, France
INERIS, Verneuil-En-Halatte, France
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of symptoms severity | 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 | 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 | at 14 months | At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life evaluation | at 14 months. | At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36) |
| Compliance to the study design | At each Visit (Day 0, Month 1, Month 6 and month 14) | — |
Countries
France
Outcome results
None listed