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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Nasal Polyposis

Treatments: Device: fMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03979716

2018-A03215-50

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Anosmic patients

Experimental group

Treatment:

Device: fMRI

Hyposmic patients

Experimental group

Treatment:

Device: fMRI

Normosmic patients

Experimental group

Treatment:

Device: fMRI