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

Not Applicable

Completed

• Conditions: Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
• Interventions: Other: Individual medical Care; Other: Individual electromagnetic exposures

• Registration Number: NCT01854801
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2012-03-09
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Primary Completion: 2015-05-30
• Study Completion: 2016-04-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Individual medical Care	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.
Experimental	Individual electromagnetic exposures	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.

Primary Outcome Measures

Name	Time	Method
Measurement of symptoms severity	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.
Measurement of symptoms frequency	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.
Sensitivity to electromagnetic fields	at day 0	At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluation	day 0	At visit1 (day 0), 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)

Trial Locations

Locations (1)

Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre; 🇫🇷 Paris, France