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

November 17, 2020 updated by: NGUYEN, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anosmic patients
Device: fMRI
fMRI examination
EXPERIMENTAL: Hyposmic patients
Device: fMRI
fMRI examination
EXPERIMENTAL: Normosmic patients
Device: fMRI
fMRI examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Brain activity
Time Frame: 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).
6 months after the last inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Brain activity
Time Frame: 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.
6 months after the last inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Duc Trung NGUYEN, MD, PhD, MPH, University Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 23, 2019

Primary Completion (ANTICIPATED)

June 23, 2021

Study Completion (ANTICIPATED)

June 23, 2021

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (ACTUAL)

June 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A03215-50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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