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

Nasal Polyposis Clinical Trial

— ODORAT_IRMf  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979716
• Other study ID #: 2018-A03215-50
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: June 23, 2021

Study information

• Verified date: November 2020
• Source: Central Hospital, Nancy, France
• Contact: Duc Trung NGUYEN, MD, PhD, MPH
• Phone: 33383155409
• Email: dt.nguyen[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Polyposis
• Nasal Polyps

Intervention

Device:
• fMRI
fMRI examination

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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