Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields (IEI-CEM)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
• Intervention / Treatment: Other: Individual medical Care; Other: Individual electromagnetic exposures

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Individual medical Care; Individual medical care in occupational and environmental diseases centers; Other: Individual 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

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: ANSES, France; INERIS, Verneuil-En-Halatte, France
• Investigators: Study Director: 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)

Publications and helpful links

Helpful Links

• The link presents the recruiting centers

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2012
• Primary Completion (ACTUAL): May 30, 2015
• Study Completion (ACTUAL): April 30, 2016

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (ESTIMATE): May 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Radiofrequency; Idiopathic; Environmental; Mobile phone; DECT; IEI-EMF; WI-FI; Electro-sensitivity; EHS; Intolerance fields
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Disorders of Environmental Origin; Environmental Illness; Multiple Chemical Sensitivity
• Other Study ID Numbers: P100120