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

Not Applicable

• Conditions: Nasal Polyposis
• Interventions: Device: fMRI

• Registration Number: NCT03979716
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-12-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-06-23
• Study Completion: 2021-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyposmic patients	fMRI	-
Normosmic patients	fMRI	-
Anosmic patients	fMRI	-

Primary Outcome Measures

Name	Time	Method
Functional Brain activity	6 months after the last inclusion	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).

Secondary Outcome Measures

Name	Time	Method
Functional Brain activity	6 months after the last inclusion	Changes in Blood Oxygen Level Dependent (BOLD) measurements in olfactory areas during calibrated olfactory stimuli before and after NP surgery.

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Nancy, France