Impact of Structural and Microenvironmental Abnormalities in Olfactory Cleft on Olfaction in CRS

NCT06834477 | Not Yet Recruiting DMC

• 1 other identifier: 9059102
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (CRS)

Keywords

olfactory cleft; olfactory dysfunction

Outcome Measures

Primary Outcomes (1)

• Sniffin Sticks Test

  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.

  Immediately before surgery

Secondary Outcomes (12)

• 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

Study Arms (2)

Patients with CRS admitted for endoscopic sinus surgery

Other: Computed Tomography

healthy controls undergoing surgery for the deviated septum

Other: Computed Tomography

Interventions

Computed Tomography OTHER

low-dose CT is taken

Also known as: collection of superior turbinate biopsy specimens, collection of olfactory cleft mucus

Patients with CRS admitted for endoscopic sinus surgery; healthy controls undergoing surgery for the deviated septum

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosed with CRS based on the diagnostic criteria of the EPOS guideline.
• Provision of signed and dated informed consent form.
• Patients with CRS admitted to the hospital awaiting endoscopic sinus surgery.
• Healthy controls undergoing surgery for the deviated septum.
• Provision of signed and dated informed consent form.

You may not qualify if:

• 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
• Patients with nasal polyps, sinusitis, nasal cavity tumors and other diseases.
• Patients with hyposmia or anosmia.
• Patients with diagnosed neurodegenerative disease.
• Patients who are mentally or physically unable to perform olfactory tests.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

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

Beijing, Haidian District, 10019, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mucus from the olfactory cleft and biopsy specimens from the posterior end of the superior turbinate

Central Study Contacts

Dawei Wu, MD, PhD

CONTACT

+86-10-13522503401; davidwuorl@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 19, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): March 14, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)