Development of A Multi-section Olfactory Cleft Opacity Staging System in Patients With CCAD

January 24, 2026 updated by: Dawei Wu, Peking University Third Hospital

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • People's Republic of China
      • Beijing, People's Republic of China, China, 10019
        • Department of Otolaryngology Head and Neck Surgery, Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients were recruited from the Department of Otolaryngology at Peking University Third Hospital in clinic.

Description

Inclusion Criteria for patient group:

  1. Diagnosed with CCAD based on the diagnostic criteria of the EPOS guideline.
  2. Provision of signed and dated informed consent form.

Inclusion Criteria for control group:

  1. Diagnosed with CRS (non-CCAD) based on the diagnostic criteria of the EPOS guideline.
  2. Provision of signed and dated informed consent form.

Exclusion Criteria for patient group:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CCAD
Other: Computer Tomography
low-dose CT is taken
Other Names:
  • collection of the percentage of peripheral blood eosinophils
non-CCAD patients with chronic rhinosinusitis
Other: Computer Tomography
low-dose CT is taken
Other Names:
  • collection of the percentage of peripheral blood eosinophils

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the novel olfactory cleft CT scoring system for imaging assessment in CCAD patients
Time Frame: 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.
Immediately after CT scans
Predictive performance of the novel olfactory cleft CT scoring system
Time Frame: 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.
Immediately after CT scans

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between novel olfactory cleft CT scores in different regions and CCAD diagnosis
Time Frame: Immediately after CT scans
Analyze the differences in scoring across various anatomical subregions in the CCAD group and identify the most diagnostically relevant regions.
Immediately after CT scans
Association between the novel olfactory cleft CT score, olfactory function, and eosinophil percentage
Time Frame: Immediately after CT scans
Investigate the relationship between the novel CT scoring system and olfactory dysfunction, as well as its potential to reflect Type 2 inflammation (eosinophilic activity).
Immediately after CT scans

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9059105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will decide whether to share the individual participant data after the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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