跳至主要内容
临床试验/NCT07380945
NCT07380945尚未招募不适用

Development of A Multi-section Olfactory Cleft Opacity Staging System in Patients With Central Compartment Atopic Disease (CCAD)

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Evaluation of the novel olfactory cleft CT scoring system for imaging assessment in CCAD patients

研究概览

简要总结

This study aims to develop a modified CT scoring system to evaluate the association between olfactory cleft obstruction patterns and olfactory dysfunction in patients with central region atopic disease (CCAD).

The main questions that the clinical trial aims to answer are: Can this modified CT scoring system be used to assess the degree of olfactory impairment in patients with CCAD? How well does the modified CT score correlate with the patient's olfaction compared to the traditional CT score?

详细描述

Olfactory dysfunction is one of the important clinical manifestations of patients with central compartment atopic disease (CCAD), whose pathological mechanism has not been fully elucidated. Previous studies have shown that physical blockage of Olfactory Cleft (OC) may block odor molecules from reaching the olfactory mucosa in the olfactory region.

At present, there is still a lack of systematic standards for imaging evaluation of olfactory obstruction patterns. Traditional CT scores are mostly based on the percentage of occlusion area in a single dimension, which is difficult to reflect the turbidity of the anterior and posterior OC. The anterior olfactory cleft serves as the main entrance to the odor molecules, and its apical and middle lower blockage may have different effects on olfactory conduction. Therefore, it is urgent to establish a regionally divided CT scoring system to more accurately analyze the spatial characteristics of olfactory cleft opacification in CCAD patients and its correlation with olfactory function.

This prospective study aims to develop an improved olfactory CT scores evaluation system to reveal the anatomical mechanism of olfactory dysfunction in patients with CCAD. All the participants (n=??) had undergone:

  1. Clinical assessment of olfactory function Using the Sniffin' Sticks Test to evaluate olfaction. The scores of the three tests of odor threshold (OT), odor discrimination (OD) and odor identification (OI) are added to the total TDI score. TDI with a total score of 48 points is normal for people >30.75 points, ≤30.75 is classified as olfactory disorder, among which 16-30 indicates hyposmia and <16 indicates anosmia. Patients are divided into three groups according to the TDI score.
  2. Traditional CT scores The olfactory cleft was considered to start at the anterior most olfactory filament (the anterior plane of middle turbinate) and end just anterior to the face of the sphenoid sinus. A computed tomography (CT) scan was performed to evaluate the OC opacification. The anterior end of the superior turbinate is boundary, and the OC is divided into two parts: anterior and posterior. The OC opacifications, in which the normal airway filled with a value representing soft tissue and /or presence of close contact between the nasal turbinates and the nasal septum, were graded on a scale of 0-4 by the ratio of the opacified area to the whole area of the corresponding region of the olfactory cleft, with 0 (no opacification), 1 (25%), 2 (25%-50%), 3 (50%-75%), and 4 (>75%).
  3. Modified olfactory cleft scores The scores of the independently assessed regions including the left anterior, left posterior, right anterior, and right posterior olfactory cleft are summed to obtain the anterior (left anterior and right anterior), posterior (left posterior and right posterior) , and total scores. Specifically, the opacification of each OC subregion is independently assessed, with a score of 1 if unilateral opacity is observed, 2 points for bilateral opacity, and 0 if none.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for patient group:
  • Diagnosed with CCAD based on the diagnostic criteria of the EPOS guideline.
  • Provision of signed and dated informed consent form.
  • Inclusion Criteria for control group:
  • Diagnosed with CRS (non-CCAD) based on the diagnostic criteria of the EPOS guideline.
  • Provision of signed and dated informed consent form.

排除标准

  • for patient group:
  • Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks.
  • Patients who have had prior sinus surgery.
  • Patients with fungal sinusitis, inverted papilloma, or other nasal diseases.
  • Patients with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses.
  • Patients who are mentally or physically unable to perform olfactory tests

研究组 & 干预措施

Patients with CCAD

干预措施: Computer Tomography (Other)

non-CCAD patients with chronic rhinosinusitis

干预措施: Computer Tomography (Other)

结局指标

主要结局

Evaluation of the novel olfactory cleft CT scoring system for imaging assessment in CCAD patients

时间窗: Immediately after CT scans

Validation of the novel CT scoring system for superior characterization of olfactory cleft obstruction compared to the traditional CT scoring system.

Predictive performance of the novel olfactory cleft CT scoring system

时间窗: Immediately after CT scans

Construct a predictive model for CCAD using logistic regression, incorporating both the novel CT score and peripheral blood eosinophil percentage, and compare it with the traditional olfactory cleft CT scoring system.

次要结局

  • Correlation between novel olfactory cleft CT scores in different regions and CCAD diagnosis(Immediately after CT scans)
  • Association between the novel olfactory cleft CT score, olfactory function, and eosinophil percentage(Immediately after CT scans)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawei Wu

Associate Researcher

Peking University Third Hospital

研究点 (1)

Loading locations...

相似试验