Clinical trial NCT01854801: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields
Official title: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
Keywords: IEI-EMF
WI-FI
DECT
Electro-sensitivity
Radiofrequency
EHS
Idiopathic
Environmental
Intolerance fields
Mobile phone
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ANSES, France
name: INERIS, Verneuil-En-Halatte, France
First posted: 2013-05-16
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Measurement of symptoms severity
timeFrame: At 12 months after inclusion .
measure: Measurement of symptoms frequency
timeFrame: At 12 months after inclusion
measure: Sensitivity to electromagnetic fields
timeFrame: at 14 months
measure: Measurement of symptoms frequency
timeFrame: At 1 month after inclusion
measure: Measurement of symptoms severity
timeFrame: At 1 month after inclusion
measure: Sensitivity to electromagnetic fields
timeFrame: at day 0
Secondary outcomes:
measure: Quality of life evaluation
timeFrame: at 14 months.
measure: Compliance to the study design
timeFrame: At each Visit (Day 0, Month 1, Month 6 and month 14)
measure: Quality of life evaluation
timeFrame: day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre
Study officials:
affiliation: Service de Pathologie Professionnelle, Hopital Cochin, AP-HP, Paris
name: Lynda BENSEFA-COLAS, MD
role: STUDY_DIRECTOR
affiliation: INERIS (Institut National de l'EnviRonnement Industriel et des RisqueS)
name: Rene de SEZE, MD
role: STUDY_DIRECTOR
References: