Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields (IEI-CEM)
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| ClinicalTrials.gov Identifier: NCT01854801 |
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Recruitment Status :
Completed
First Posted : May 16, 2013
Last Update Posted : August 1, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields | Other: Individual medical Care Other: Individual electromagnetic exposures | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 79 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields |
| Actual Study Start Date : | March 9, 2012 |
| Actual Primary Completion Date : | May 30, 2015 |
| Actual Study Completion Date : | April 30, 2016 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
- 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.
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854801
| France | |
| Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre | |
| Paris, France, 75014 | |
| 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) |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01854801 |
| Other Study ID Numbers: |
P100120 |
| First Posted: | May 16, 2013 Key Record Dates |
| Last Update Posted: | August 1, 2017 |
| Last Verified: | July 2017 |
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IEI-EMF WI-FI DECT Electro-sensitivity Radiofrequency |
EHS Idiopathic Environmental Intolerance fields Mobile phone |
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Multiple Chemical Sensitivity Environmental Illness Hypersensitivity Immune System Diseases Disorders of Environmental Origin |