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Trial record 5 of 11 for:    Multiple Chemical Sensitivity

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01854801
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : August 1, 2017
Sponsor:
Collaborators:
ANSES, France
INERIS, Verneuil-En-Halatte, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE April 24, 2013
First Posted Date  ICMJE May 16, 2013
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE March 9, 2012
Actual Primary Completion Date May 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
  • Measurement of symptoms severity [ Time Frame: At 12 months after inclusion . ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
  • Measurement of symptoms severity [ Time Frame: At 1 month after inclusion and at 12 months. ]
    At month 1 and at 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.
  • Measurment of symptoms frequency [ Time Frame: At 1 month after inclusion and at 12 months. ]
    At month 1 and at 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: Visit 1 (day 0)/Visit 3 (14 months) ]
    At visit 1 (day 0) and visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
  • Quality of life evaluation [ Time Frame: at 14 months. ]
    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) ]
  • Quality of life evaluation [ Time Frame: day 0 ]
    At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
  • Quality of life evaluation [ Time Frame: At visit1 (day 0) and visit 3 (14 months) . ]
    At visit1 (day 0) and 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields
Official Title  ICMJE Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Other: Individual medical Care
  • Other: Individual electromagnetic exposures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2014)
79
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2013)
110
Actual Study Completion Date  ICMJE April 30, 2016
Actual Primary Completion Date May 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01854801
Other Study ID Numbers  ICMJE P100120
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • ANSES, France
  • INERIS, Verneuil-En-Halatte, France
Investigators  ICMJE
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)
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP