Testing a new device for improving sense of smell in patients with olfactory dysfunction
Modified Olfactory Training for Patients With Olfactory Disfunction:A Randomized Clinical Trial
This study is testing a new device to see if it can help adults with smell problems improve their sense of smell better than a regular device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06353139 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a modified olfactory training device designed to treat olfactory disorders in adults. Participants will be divided into two groups, one using the conventional device and the other using the modified device, which features bi-directional airflow, positive pressure, and voice prompts. The study will recruit 72 patients diagnosed with olfactory impairment and assess their outcomes through olfactory training and follow-up visits. The goal is to determine if the modified device offers significant improvements over traditional methods.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with olfactory disorders who have a TDI score of less than 30.75.
Not a fit: Patients with chronic diseases or those who have recently taken certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from olfactory dysfunction.
How similar studies have performed: While olfactory training is a recognized approach, the specific modifications in this device represent a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients diagnosed with olfactory disorder when TDI score was less than 30.75. 2. Patients would perform Sniffin' Sticks examination. 3. Voluntarily sign the informed consent form 4. Able to undergo olfactory training and participate in follow-up visits Exclusion Criteria: 1. Smoking 2. Combined with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc. 3. Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks will be excluded. 4. Patients who cannot tolerate olfactory function testing and treatment 5. Severe coexisting diseases: such as malignant tumors, life expectancy \<2 years 6. Patients who are pregnant or planning to become pregnant 7. According to the researcher's judgment, the patient is unable to complete this study or cannot comply with the requirements of this study (such as memory or behavioral abnormalities, depression, heavy drinking, past breach of contract)
Where this trial is running
Beijing, Beijing
- Dawei Wu — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Dawei Wu, MD, PhD
- Email: davidwuorl@163.com
- Phone: 13522503401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.