An interventional study of Sniffin Stick Test and numerical evaluation scale for olfaction in Nasal Polyps, Chronic Rhinosinusitis With Nasal Polyps and Olfaction Disorders, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Inclusion Criteria for patients :
Inclusion Criteria for control group :
Exclusion Criteria for patients :
Exclusion Criteria for control group :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Sniffin Stick Test · Other: numerical evaluation scale for olfaction · Other: numerical evaluation scale for nasal obstruction · Other: nasal outcome test · Biological: dosage of 17 cytokines
Diagnostic Test: Sniffin Stick Test · Other: nasal outcome test · Biological: dosage of 17 cytokines
The test consists of odorous rods that are presented to the patient's nose. It consists of 3 parts different, with 3 sets of corresponding sticks: an olfactory threshold test, an olfactory discrimination test and an olfactory identification test. The final score, out of 48, is the sum of the olfactory threshold, discrimination and identification scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.
numerical rating scale from 0 (no smell) to 10 (perfect smell)
numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)
list of symptoms and social/emotional consequences of rhino-sinusitis. 16 questions that the patient must code from "no problem" to "serious problem" over the last 15 days
dosage of 17 cytokines : G-CSF, GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, IL-17A, MCP-1 (MCAF), MIP-1β,TNF-α
expression rate of TNF-alpha in biopsies
The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score.
Time frame: 2 months
Sniffin Stick test score
The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score. Sniffin Stick test score : The final score, out of 48, is the sum of the olfactory threshold (out of 16), discrimination (out of 16) and identification (out of 16) scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.
Time frame: 2 months
Olfactory Cleft Endoscopic Score
measured at control and patients. 5 endoscopic feature to be completed : * discharge : 0= none or scant clear/thin drainage (normal) ; 1= more abundant, thicker clear/white drainage (not normal but not purulent) ; 2= thicker, more abundant, discolored/purulent drainage. * polyps : 0= none ; 1= discrete polyps partially narrowing/blocking the olfactory cleft (\<50%) ; 2= discrete polyps completely narrowing/blocking the olfactory cleft (\>50%). * edema : 0= none ; 1= swelling partially narrowing/blocking the olfactory cleft (\<50%) ; 2= swelling completely narrowing/blocking the olfactory cleft (\>50%). * crusting : 0= none ; 1= mild ; 2= severe * scarring : 0= none ; 1= mild ; 2= severe
Time frame: 2 months
expression rate of TNF-alpha in polyps
measured at control and patients.
Time frame: 2 months
dosage of cytokines G-CSF
measured at control and patients.
Time frame: 2 months
dosage of cytokines GM-CSF
measured at control and patients.
Time frame: 2 months
dosage of cytokines IFN-γ
measured at control and patients.
Time frame: 2 months
dosage of cytokines IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A
measured at control and patients.
Time frame: 2 months
dosage of cytokines MCP-1
measured at control and patients.
Time frame: 2 months
dosage of cytokines MIP-1β
measured at control and patients.
Time frame: 2 months
dosage of cytokines MCAF
measured at control and patients.
Time frame: 2 months
Plan to share: No
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