Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields

Not Applicable

Completed

• Conditions: Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

• Registration Number: NCT01854801
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2012-03-09
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Primary Completion: 2015-05-30
• Study Completion: 2016-04-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measurement of symptoms severity	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.
Measurement of symptoms frequency	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.
Sensitivity to electromagnetic fields	at day 0	At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluation	day 0	At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)
Compliance to the study design	At each Visit (Day 0, Month 1, Month 6 and month 14)

Trial Locations

Locations (1)

Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre; 🇫🇷 Paris, France