Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields (IEI-CEM)
Primary Purpose
Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Individual medical Care
Individual electromagnetic exposures
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields focused on measuring IEI-EMF, WI-FI, DECT, Electro-sensitivity, Radiofrequency, EHS, Idiopathic, Environmental, Intolerance fields, Mobile phone
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.
Sites / Locations
- Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Sensitivity to electromagnetic fields
At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.
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.
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.
Sensitivity to electromagnetic fields
At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.
Secondary Outcome Measures
Quality of life evaluation
At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36)
Compliance to the study design
Quality of life evaluation
At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)
Full Information
NCT ID
NCT01854801
First Posted
April 24, 2013
Last Updated
July 31, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ANSES, France, INERIS, Verneuil-En-Halatte, France
1. Study Identification
Unique Protocol Identification Number
NCT01854801
Brief Title
Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields
Acronym
IEI-CEM
Official Title
Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 9, 2012 (Actual)
Primary Completion Date
May 30, 2015 (Actual)
Study Completion Date
April 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ANSES, France, INERIS, Verneuil-En-Halatte, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Keywords
IEI-EMF, WI-FI, DECT, Electro-sensitivity, Radiofrequency, EHS, Idiopathic, Environmental, Intolerance fields, Mobile phone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Individual medical Care
Intervention Description
Individual medical care in occupational and environmental diseases centers
Intervention Type
Other
Intervention Name(s)
Individual electromagnetic exposures
Intervention Description
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
Primary Outcome Measure Information:
Title
Measurement of symptoms severity
Description
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.
Time Frame
At 12 months after inclusion .
Title
Measurement of symptoms frequency
Description
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.
Time Frame
At 12 months after inclusion
Title
Sensitivity to electromagnetic fields
Description
At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.
Time Frame
at 14 months
Title
Measurement of symptoms frequency
Description
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.
Time Frame
At 1 month after inclusion
Title
Measurement of symptoms severity
Description
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.
Time Frame
At 1 month after inclusion
Title
Sensitivity to electromagnetic fields
Description
At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.
Time Frame
at day 0
Secondary Outcome Measure Information:
Title
Quality of life evaluation
Description
At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36)
Time Frame
at 14 months.
Title
Compliance to the study design
Time Frame
At each Visit (Day 0, Month 1, Month 6 and month 14)
Title
Quality of life evaluation
Description
At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda BENSEFA-COLAS, MD
Organizational Affiliation
Service de Pathologie Professionnelle, Hopital Cochin, AP-HP, Paris
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rene de SEZE, MD
Organizational Affiliation
INERIS (Institut National de l'EnviRonnement Industriel et des RisqueS)
Official's Role
Study Director
Facility Information:
Facility Name
Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.radiofrequences.gouv.fr/spip.php?article102
Description
The link presents the recruiting centers
Learn more about this trial
Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields
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