Chronic Rhinosinusitis, Olfactory Dysfunction
Conditions
Keywords
olfactory dysfunction, chronic rhinosinusitis, endoscopic sinus surgery, olfactory training
Brief 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?
Detailed description
Endoscopic sinus surgery is an effective treatment for treating olfactory dysfunction related to chronic rhinosinusitis. However, recent studies have shown that most patients experience a return of olfactory function to preoperative levels within months to a year after surgery. Clinically, olfactory training after endoscopic sinus surgery has been proven beneficial for the olfactory recovery. The improved olfactory training device, based on a nasal bidirectional drug delivery system, can increase the deposition rate in the olfactory fissure region and improve the efficiency of olfactory training. In this study, the investigators planned to recruit 213 patients and divided them into three groups for control group and olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on changes in cognitive function and the comparison of the outcomes of the three groups.
Interventions
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.
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 can effectively target the olfactory cleft area to provide anti-inflammatory effects.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Olfactory cleft CT score | Baseline,Month 3,Month 6,Month 12 | — |
| Olfactory cleft endoscopy scale (OCES) | Baseline,Month 3,Month 6,Month 12 | 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 | Baseline,Month 3,Month 6,Month 12 | 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) | Baseline,Month 3,Month 6,Month 12 | 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. |
| Olfactory-Visual Analogue Scale (VAS) | Baseline,Month 3,Month 6,Month 12 | Subjects rate the impact of smell loss on their mood, ability to enjoy food, social interactions, safety, personal hygiene, sex life, ability to cook food, appetite and change in weight from 0 (no impact) to 10 (most impact) for a maximum score of 90. Higher olfactory-VAS scores reflect more severe impacts on daily life. |
Countries
China
Contacts
Primary ContactDawei Wu, MD, PhD
Outcome results
None listed