The Influence of Structural and Microenvironmental Abnormalities in the Olfactory Cleft on Olfactory Function in Patients With Chronic Rhinosinusitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Sniffin Sticks Test
Study Overview
Brief Summary
The purpose of this research is to investigate the impact of structural abnormalities and microenvironmental changes in the olfactory cleft on olfactory function in patients with chronic rhinosinusitis (CRS). It sought to elucidate the complex relationships among structural abnormalities, microenvironmental changes, and inflammatory factors contributing to olfactory dysfunction through a multidimensional assessment encompassing imaging, aerodynamics, biomarker , and histopathology analysis.
Detailed Description
Olfactory dysfunction (OD) is a critical symptom among patients with CRS, affecting up to 83% of individuals with the condition. Currently, it is considered that the inflammation in olfactory cleft is a central factor contributing to both conductive and sensorineural OD in patients with CRS. Inflammation in the olfactory cleft could impair olfaction by altering the mucosal and mucus microenvironment thereby causing damage to the olfactory neuroepithelium, by physically impeding delivery of odorant-containing air to the olfactory cleft, or a combination of both mechanisms.
Existing studies mainly focus on isolated mechanisms, such as inflammation-induced physical obstruction or injury of olfactory epithelium. However, limited research has explored how structural abnormalities and microenvironmental changes in the olfactory cleft might interact to contribute to olfactory dysfunction. This research aimed to evaluate the relationship between structural abnormalities and microenvironmental changes in the olfactory cleft and their impact on olfactory function in patients with CRS using a multidimensional approach integrating imaging, pathology, and functional analysis.
This is a retrospective study. Patients with CRS admitted for endoscopic sinus surgery (n = 70) and healthy controls undergoing surgery for the deviated septum (n = 10) were included. All the participants had undergone:
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Clinical assessment of olfactory function and quality of life
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Olfactory measurements had been conducted preoperatively using the Sniffin' Sticks Test to evaluate olfactory threshold (OT), olfactory discrimination (OD), olfactory identification (OI), and the overall composite scores (TDI). A TDI score > 30.75, 16-30.75, and ≤ 15 indicates normosmia, hyposmia, and anosmia, respectively.
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The 22-item Sino-Nasal Outcome Test (SNOT-22) had been administered to evaluate patient-reported subjective outcomes.
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The Questionnaire of Olfactory Disorders Negative Statements (QOD-NS) was utilized to assess the olfactory-specific quality of life.
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The visual analog scale（VAS）for olfaction was employed to measure patients' self-reported olfaction.
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Evaluation of structural abnormalities and patency of the olfactory cleft
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Sniffin Sticks Test
Time Frame: Immediately before surgery
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 TDI score, out of 48, is the sum of the olfactory threshold, discrimination and identification scores.
Secondary Outcomes
- The 22-item Sino-Nasal Outcome Test (SNOT-22)(Immediately before surgery)
- Visual analog scale（VAS）for olfaction(Immediately before surgery)
- The Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)(Immediately before surgery)
- The original version of olfactory cleft CT score(during routine preoperative CT imaging)
- The modified version of olfactory cleft CT score(during routine preoperative CT imaging)
- Airflow velocity in the olfactory cleft(Immediately after CT scans)
- Mass flowrate in the olfactory cleft(Immediately after CT scans)
- Airflow ratio in the olfactory cleft(Immediately after CT scans)
- The level of eosinophil-derived neurotoxin, galectin-10 and otherTh1/Th2-related cytokines in olfactory cleft mucus(Immediately after surgery)
- Clinical phenotypes classification：CRS with nasal polyps (CRSwNP) or CRS without nasal polyps (CRSsNP)(During preoperative physical and imaging examinations)
- Histopathological phenotypes classification: eosinophilic CRS or non-eosinophilic CRS(Immediately after surgery)
- Immunohistochemical staining of olfactory marker protein (OMP) in olfactory epithelium(Immediately after surgery)
Investigators
Dawei Wu
Associate Researcher
Peking University Third Hospital