The Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With CRS

NCT06837051 · tracked via the Priya Life Science China tracker

Sponsor

Peking University Third Hospital

Phase

Not applicable

Started

2025-03-14

Last updated

2025-02-20

Condition(s) studied

Olfactory DysfunctionChronic Rhinosinusitis

Investigational drug(s) / intervention(s)

Conventional olfactory training deviceModified olfactory training deviceBudesonide irrigation

Conventional olfactory training device: Four odorants are used: phenyl ethyl alcohol (PEA): rose, menthol: mint, citronellal: lemon, and eugenol: cloves. Training patients will receive four glass vials. Each contains one odorant (5 mL, soaked in cotton pads to prevent spilling) and is labeled with the name of the odorant. Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

Modified olfactory training device: The modified olfactory training device is based on the nasal bidirectional drug delivery system. The device uses breathing pressure to create positive pressure, significantly increasing the deposition rate of odors in the olfactory cleft area. Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

Budesonide irrigation: Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

Study summary

The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:

Is it possible that the device can treat postoperative olfactory dysfunction in patients with chronic sinusitis? Compared to the conventional device, how efficient is the modified olfactory training device for treating postoperative olfactory dysfunction in patients with chronic sinusitis?

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. A diagnosis of CRSsNP based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS20). 2. The duration after endoscopic sinus surgery is 3months. 3. Olfactory dysfunction confirmed with the Sniffin's Sticks psychophysical test (TDI score≦30.5) . 4. Willingness to participate in this study and sign the informed consent form (ICF). Exclusion Criteria: 1. Patients with olfactory impairment due to traumatic, congenital, toxic/drug-induced causes, tumors, or post-upper respiratory infections. 2. Lund-Mackay olfactory cleft score \> 0. 3. Patients with severe comorbidities, such as malignant tumors. 4. Current or planned pregnancy prior to the end of study. 5. Patients who are unable to complete the study or are unable to comply with the requirements of the study (such as inability to tolerate olfactory function testing and treatment, memory or behavioral abnormalities, depression, smoking, heavy alcohol use, previous delinquent behavior)

Primary outcome measure(s)

The Sniffin's Sticks test — Baseline,Month 3,Month 6,Month 12
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)( more than 6 scores)

Trial sites (1)

Facility	City	Region	Status
Beijing	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06837051 on ClinicalTrials.gov ↗ ← All trials in China