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

NCT03979716 | Unknown

• 1 other identifier: 2018-A03215-50
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Polyposis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional Brain activity

  6 months after the last inclusion

Study Arms (3)

Anosmic patients

EXPERIMENTAL

Device: fMRI

Hyposmic patients

EXPERIMENTAL

Device: fMRI

Normosmic patients

EXPERIMENTAL

Device: fMRI

Interventions

fMRI DEVICE

fMRI examination

Anosmic patients; Hyposmic patients; Normosmic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Nasal Polyps

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Duc Trung NGUYEN, MD, PhD, MPH

  University Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duc Trung NGUYEN, MD, PhD, MPH

CONTACT

33383155409; dt.nguyen@chru-nancy.fr

Gabriela HOSSU, PhD

CONTACT

33383155096; g.hossu@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 7, 2019
• Study Start: December 23, 2019
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

FR (1)