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

Primary Purpose

Nasal Polyposis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nasal Polyposis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Anosmic patients

Hyposmic patients

Normosmic patients

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Functional Brain activity
Changes in Blood Oxygen Level Dependent (BOLD) measurements in olfactory areas during calibrated olfactory stimuli before and after NP surgery.

Full Information

First Posted
May 23, 2019
Last Updated
November 17, 2020
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03979716
Brief Title
Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging
Acronym
ODORAT_IRMf
Official Title
Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
June 23, 2021 (Anticipated)
Study Completion Date
June 23, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyposis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anosmic patients
Arm Type
Experimental
Arm Title
Hyposmic patients
Arm Type
Experimental
Arm Title
Normosmic patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
fMRI
Intervention Description
fMRI examination
Primary Outcome Measure Information:
Title
Functional Brain activity
Description
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).
Time Frame
6 months after the last inclusion
Secondary Outcome Measure Information:
Title
Functional Brain activity
Description
Changes in Blood Oxygen Level Dependent (BOLD) measurements in olfactory areas during calibrated olfactory stimuli before and after NP surgery.
Time Frame
6 months after the last inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duc Trung NGUYEN, MD, PhD, MPH
Phone
33383155409
Email
dt.nguyen@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela HOSSU, PhD
Phone
33383155096
Email
g.hossu@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duc Trung NGUYEN, MD, PhD, MPH
Organizational Affiliation
University Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duc Trung NGUYEN, MD, PhD, MPH
Phone
33383155409
Email
dt.nguyen@chru-nancy.fr

12. IPD Sharing Statement

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

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