Clinical trial NCT06837051: The Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With CRS
Official title: Protocol for a Randomized Controlled Trial Evaluating the Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Olfactory Dysfunction
Chronic Rhinosinusitis
Keywords: olfactory dysfunction
chronic rhinosinusitis
endoscopic sinus surgery
olfactory training
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: The Sniffin's Sticks test
timeFrame: Baseline,Month 3,Month 6,Month 12
Secondary outcomes:
measure: Olfactory cleft CT score
timeFrame: Baseline,Month 3,Month 6,Month 12
measure: Olfactory cleft endoscopy scale (OCES)
timeFrame: Baseline,Month 3,Month 6,Month 12
measure: OB volume measurement
timeFrame: Baseline,Month 3,Month 6,Month 12
measure: Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)
timeFrame: Baseline,Month 3,Month 6,Month 12
measure: Olfactory-Visual Analogue Scale (VAS)
timeFrame: Baseline,Month 3,Month 6,Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing
state: Beijing
Study officials:
References: