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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Anosmic patients||
|Experimental: Hyposmic patients||
|Experimental: Normosmic patients||
- 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).
- 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.
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
|Contact: Duc Trung NGUYEN, MD, PhD, MPHemail@example.com|
|Contact: Gabriela HOSSU, PhDfirstname.lastname@example.org|
|CHRU de Nancy||Not yet recruiting|
|Nancy, France, 54000|
|Contact: Duc Trung NGUYEN, MD, PhD, MPH 33383155409 email@example.com|
|Principal Investigator:||Duc Trung NGUYEN, MD, PhD, MPH||University Hospital, Nancy, France|