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

This study is ongoing, but not recruiting participants.
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: June 13, 2014
Last verified: June 2014
  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)


Enrollment: 79
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854801

Locations
France
Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre
Paris, France, 75014
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: June 13, 2014
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 September 18, 2014