Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging

Study Overview
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Brief Summary
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Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life. The aim of this study is to show brain activity differences in olfactory areas before and after surgery in each patient and between patient groups (normosmic, hyposmic and anosmic one) using functional Magnetic Resonance Imaging (fMRI). Brain activity will be measured by the intensity of brain signals and of the size of olfactory areas during olfactory stimulation before and after surgery. We suppose that fMRI could predict whether or not the patient will be able to recover smell after surgery.

Official Title
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Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne

Conditions
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Nasal Polyposis

Intervention / Treatment
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* Device: fMRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with nasal polyposis managed in the department of otorhinolaryngology and head and neck surgery of Nancy University Hospital, Adult Patients, Justifying a surgical treatment for nasal polyposis, Present hyposmia, anosmia or normosmia before surgery (confirmed by threshold and identification tests of the Sniffin' Stick kit), Affiliated with or beneficiary of a social security scheme, Having received complete information about the study and having signed an informed consent form. Exclusion Criteria: General contraindications to Magnetic Resonance Imaging, Female of childbearing age without effective contraception, Persons referred in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code, Qualitative sense of smell disorder (cacosmia, hyperosmia, phantosmia, parosmia), Smell disorders with neurological, post-traumatic, or neurodegenerative origin.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anosmic patients<br> | Device: fMRI<br>* fMRI examination<br>|
| Experimental: Hyposmic patients<br> | Device: fMRI<br>* fMRI examination<br>|
| Experimental: Normosmic patients<br> | Device: fMRI<br>* fMRI examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Brain activity | Blood Oxygen Level Dependent (BOLD) measures in olfactory areas during calibrated olfactory stimuli in patients with NP whose olfactory function is clinically normal (normosmia), decreased (hyposmia) or absent (anosmia). | 6 months after the last inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Brain activity | Changes in Blood Oxygen Level Dependent (BOLD) measurements in olfactory areas during calibrated olfactory stimuli before and after NP surgery. | 6 months after the last inclusion |