Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging
NCT ID: NCT03979716
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-12-23
2021-06-23
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Anosmic patients
fMRI
fMRI examination
Hyposmic patients
fMRI
fMRI examination
Normosmic patients
fMRI
fMRI examination
Interventions
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fMRI
fMRI examination
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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NGUYEN
Medical Doctor
Principal Investigators
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Duc Trung NGUYEN, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Nancy, France
Locations
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CHRU de Nancy
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Duc Trung NGUYEN, MD, PhD, MPH
Role: primary
Other Identifiers
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2018-A03215-50
Identifier Type: -
Identifier Source: org_study_id