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

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ClinicalTrials.gov Identifier: NCT03979716
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Nasal Polyposis Device: fMRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Experimental: Anosmic patients Device: fMRI
fMRI examination

Experimental: Hyposmic patients Device: fMRI
fMRI examination

Experimental: Normosmic patients Device: fMRI
fMRI examination




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979716


Contacts
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Contact: Duc Trung NGUYEN, MD, PhD, MPH 33383155409 dt.nguyen@chru-nancy.fr
Contact: Gabriela HOSSU, PhD 33383155096 g.hossu@chru-nancy.fr

Locations
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France
CHRU de Nancy Not yet recruiting
Nancy, France, 54000
Contact: Duc Trung NGUYEN, MD, PhD, MPH    33383155409    dt.nguyen@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Duc Trung NGUYEN, MD, PhD, MPH University Hospital, Nancy, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03979716     History of Changes
Other Study ID Numbers: 2018-A03215-50
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nasal Polyps
Otorhinolaryngologic Diseases
Nose Diseases
Respiratory Tract Diseases
Polyps
Pathological Conditions, Anatomical