Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields Clinical Trial
— IEI-CEMOfficial title:
Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
| Verified date | July 2017 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 79 |
| Est. completion date | April 30, 2016 |
| Est. primary completion date | May 30, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | ANSES, France, INERIS, Verneuil-En-Halatte, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of symptoms severity | 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. | At 12 months after inclusion . | |
| Primary | Measurement of symptoms frequency | 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. | At 12 months after inclusion | |
| Primary | Sensitivity to electromagnetic fields | At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary. | at 14 months | |
| Primary | Measurement of symptoms frequency | 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. | At 1 month after inclusion | |
| Primary | Measurement of symptoms severity | 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. | At 1 month after inclusion | |
| Primary | Sensitivity to electromagnetic fields | At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary. | at day 0 | |
| Secondary | Quality of life evaluation | At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36) | at 14 months. | |
| Secondary | Compliance to the study design | At each Visit (Day 0, Month 1, Month 6 and month 14) | ||
| Secondary | Quality of life evaluation | At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36) | day 0 |