Evaluating a new olfactory training device for post-viral smell loss

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

This study is testing a new smell training device to see if it helps people who have lost their sense of smell after a virus recover better than a standard device.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06829706 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of a modified olfactory training device in treating patients with post-viral olfactory dysfunction. It will compare the modified device's efficacy against a conventional olfactory training device over a 12-week intervention period. The study will utilize a randomized, controlled, multi-center approach, measuring changes in olfactory ability using the Sniffer Stick Test and other secondary endpoints related to olfactory function and brain activity. The findings will help understand the mechanisms behind olfactory training in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 diagnosed with olfactory dysfunction following upper respiratory infections.

Not a fit: Patients with olfactory dysfunction due to trauma, chronic diseases, or other non-viral causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the olfactory function of patients suffering from post-viral olfactory dysfunction.

How similar studies have performed: While olfactory training has been explored in other studies, the modified approach being tested here is novel and aims to provide new insights into treatment efficacy.

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.

Where this trial is running

Beijing

• Bejing — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Dawei Wu, MD, PhD

Conditions Olfactory Dysfunction; Post Viral Olfactory Dysfunction; Olfactory Training; Modified Olfactory Training Device