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

This study is currently recruiting participants.
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
ANSES, France
INERI, Verneuil-En-Halatte, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01854801
First received: April 24, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Other: Individual medical Care
Other: Individual electromagnetic exposures

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Measurement of symptoms severity [ Time Frame: At 12 months after inclusion . ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 12 months after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 14 months ] [ Designated as safety issue: No ]
    At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.

  • Measurement of symptoms frequency [ Time Frame: At 1 month after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 1 month after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
    At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.


Secondary Outcome Measures:
  • Quality of life evaluation [ Time Frame: at 14 months. ] [ Designated as safety issue: No ]
    At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36)

  • Compliance to the study design [ Time Frame: At each Visit (Day 0, Month 1, Month 6 and month 14) ] [ Designated as safety issue: No ]
  • Quality of life evaluation [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)


Estimated Enrollment: 110
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854801

Contacts
Contact: Dominique CHOUDAT, MD, PhD +33 1 58 41 22 62 dominique.choudat@cch.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre Recruiting
Paris, France, 75014
Contact: Dominique CHOUDAT, MD, PhD    +33 1 58 41 22 62    dominique.choudat@cch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ANSES, France
INERI, 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)
  More Information

Additional Information:
No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01854801     History of Changes
Other Study ID Numbers: P100120
Study First Received: April 24, 2013
Last Updated: August 28, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
IEI-EMF
WI-FI
DECT
Electro-sensitivity
Radiofrequency
EHS
Idiopathic
Environmental
Intolerance fields
Mobile phone

Additional relevant MeSH terms:
Multiple Chemical Sensitivity
Environmental Illness
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014