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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03979716

Acronym

ODORAT_IRMf

Enrollment

Registered

2019-06-07

Start date

2019-12-23

Completion date

2021-06-23

Last updated

2020-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Polyposis

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.

Interventions

DEVICEfMRI

fMRI examination

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Contacts

Primary ContactDuc Trung NGUYEN, MD, PhD, MPH

dt.nguyen@chru-nancy.fr33383155409

Backup ContactGabriela HOSSU, PhD

g.hossu@chru-nancy.fr33383155096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026