Clinical trial NCT06829706: The Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction
Official title: A Randomized Trail Protocol to Access Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Olfactory Dysfunction
Post Viral Olfactory Dysfunction (PVOD)
Keywords: Olfactory Training
Modified Olfactory Training Device
Post Viral Olfactory Dysfunction (PVOD)
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 150
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 the modified olfactory training device effective in treating patients with post-viral olfactory dysfunction? Compared to the conventional device, how efficient is the modified olfactory training device for improving olfactory function?

Detailed description: Background The aim of this article is to present the research protocol for a randomized, controlled, multi-center, placebo study that will assess the olfactory function and the effect of an intervention based on olfactory training in patients with post-viral olfactory dysfunction, and compare it with traditional olfactory training. The sample selection will follow the multi-center principle. The olfactory training (OT) intervention will last for 12 weeks.

Evaluation The primary endpoint will be the change in olfactory ability from baseline to the 12-week intervention or control period. The intervention effect will be evaluated by the total score of the Sniffer Stick Test (SST)-Threshold, Discrimination and Identification (TDI)-Extended Version. Secondary endpoints will be changes in olfactory bulb volume and shape, olfactory-related brain area volume, olfactory and trigeminal nerve-related potentials, and cognitive questionnaires.

Conclusion（objective） The present study aimed to explore the efficacy of the modified olfactory training device (MOT), and compare COT and MOT with respect to the resultant improvement in olfactory function.

At the same time, our study will use a variety of outcome indicators to evaluate the changes in patients before and after treatment, which will lay the foundation for exploring the mechanism of olfactory training in treating patients with post-viral olfactory disorders.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years old, gender not limited.
2. Patients diagnosed with olfactory dysfunction following infections of the upper respiratory tract, as determined by Sniffin' Sticks test (including TDI value test).
3. Voluntarily signs the informed consent form.

Exclusion Criteria:

1. Patients with post-traumatic olfactory dysfunction, rhinosinusitis-related dysfunction and olfactory dysfunction caused by other reasons.
2. Patients with concomitant sinonasal disease.
3. Patients with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc.
4. Patients with serious coexisting diseases: such as malignant tumors, etc., with a life expectancy of less than 2 years.
5. Patients who cannot tolerate olfactory function testing and treatment.
6. Patients who have taken oral glucocorticoids, antibacterial drugs, anti-leukotrienes, antihistamines, or received olfactory training within four weeks will be excluded.
7. Patients who are receiving treatment that affects olfactory recovery.
8. Patients with smoking habits.
9. Patients who are already or plan to be pregnant.
10. According to the judgment of the researchers, the patient cannot complete this study or cannot comply with the requirements of this study (such as memory or behavior abnormalities, depression, heavy drinking, previous breach of contract).
11. Patients who did not consent for participating in the study.

Primary outcomes:
measure: The total scores in the "Sniffin 'Sticks" test
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
Secondary outcomes:
measure: OB volume and shape measurement
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: MRI volumetric evaluation related to GM
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: MRI volumetric evaluation related to WM
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: MRI volumetric evaluation related to CSF
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Event-related potentials (ERPs)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Questionnaire of Olfactory Disorders
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Visual analogue scale for olfactory training
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bejing
Study officials:
References: