Using auricular nerve stimulation to treat dry eye disease
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction, A Randomized Clinical Trial
PHASE1; PHASE2 · Beijing Tongren Hospital · NCT06544447
This study is testing if a new treatment using auricular nerve stimulation can help people with dry eye disease feel better.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tongren Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06544447 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in patients suffering from dry eye disease associated with meibomian gland dysfunction. A total of 270 patients will be enrolled at Beijing Tongren Hospital, where they will receive training to self-administer the treatment at home. The study will assess therapeutic effects through various questionnaires and clinical measures at baseline, and at 1, 3, and 6 months post-treatment. Statistical significance will be determined with a P value of less than 0.05.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with dry eye disease and meibomian gland dysfunction.
Not a fit: Patients with a history of certain medical conditions, such as depression, tumors, or cardiac diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients with dry eye disease.
How similar studies have performed: While the approach of using taVNS is relatively novel, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>=18 and Age \<=65. 2. Clinical diagnosis of dry eye disease with meibomian gland dysfunction. Exclusion Criteria: 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of Otorhinolaryngology surgery. 3. Pregnant or lactating women.
Where this trial is running
Beijing, Beijing Municipality
- China Beijing TongRen Hospital, Capital Medical University Beijing, China — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Dong Wu, Doctor
- Email: wudong0120@outlook.com
- Phone: 8613810988682
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.