NCT06829706

The Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction

A Randomized Trail Protocol to Access Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Olfactory Dysfunction
• Post Viral Olfactory Dysfunction (PVOD)

Interventions

Type	Name	Description
DEVICE	Conventional olfactory training device	Conventional olfactory training was designed by Hummel et al. They performed OT using four odors (phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronella, lemon; and eugenol, cloves), which are representative of four odor categories on the odor prism proposed by Henning.
DEVICE	Modified olfactory training device	Participants will use a modified olfactory training device based on expiratory pressure. Its bidirectional airflow and unidirectional pressure characteristics significantly increased the deposition rate of olfactory odors in the olfactory cleft area, making the patient feel stronger in the nasal cavity during olfactory training.
DEVICE	Conventional olfactory training device with placebo	Based on the traditional olfactory training device, four olfactory odors are replaced by placebo。

Timeline

• Start date: 2025-03-22
• Primary completion: 2027-03-22
• Completion: 2027-05-22
• First posted: 2025-02-17
• Last updated: 2025-02-17

Locations

1 site across 1 country: China