Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields Clinical Trial
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.
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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