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?
A diagnosis of CRSsNP based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS20).
The duration after endoscopic sinus surgery is 3months.
Olfactory dysfunction confirmed with the Sniffin's Sticks psychophysical test (TDI score≦30.5) .
Willingness to participate in this study and sign the informed consent form (ICF).
Patients with olfactory impairment due to traumatic, congenital, toxic/drug-induced causes, tumors, or post-upper respiratory infections.
Lund-Mackay olfactory cleft score > 0.
Patients with severe comorbidities, such as malignant tumors.
Current or planned pregnancy prior to the end of study.
Parallel
Conventional olfactory training device
DeviceFour 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
DeviceThe 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
DrugBudesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.
The Sniffin's Sticks test
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)( more than 6 scores)
Olfactory cleft CT score
Olfactory cleft endoscopy scale (OCES)
The degree of discharge, nasal polyposis, edema, crusting, and scarring scores from 0 to 2 points for each measure. The sum of the olfactory cleft score on both sides is recorded for final results that ranged from 0 to 20 points. Higher scores indicate increased disease severity of the olfactory cleft.
OB volume measurement
MRI scans are performed using a 3T GE scanner with a 8-channel phase-array head coil. OB volumes are obtained by manual bordering and following addition of all slices, which are multiplied by the slice thickness to yield volume.
Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)
The QOD-NS includes 17 negative statements, each graded from 0 (disagree) to 3 (agree) for a maximum score of 51. Higher QOD-NS scores reflect worse QoL.
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This trial is not recruiting at the moment. You can still explore other options:
