Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis
- Conditions
- Dry Eye Disease
- Interventions
- Device: Transcutaneous Auricular Vagus Nerve Stimulation
- Registration Number
- NCT04673643
- Lead Sponsor
- Beijing Tongren Hospital
- Brief Summary
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients reflux esophagitis.
Methods: We accrued 29 patients at Beijing TongRen Hospital Affiliated to Capital Medicine University of. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks and 24 weeks. Endoscopy, reflux diagnostic questionnaire (RDQ), gastrointestinal symptom rating scale (GSRS), and SF-36 were performed to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Age >=18 and Age <=70.
- Clinical diagnosis of reflux diagnostic.
- History of cirrhosis, renal impairment, tumors, thyroid disease, diabetes, Crohn's disease, or ulcerative colitis.
- History of GI or abdominal surgery.
- Pregnant or lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description taVNS group Transcutaneous Auricular Vagus Nerve Stimulation taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day. taVNS group Hyaluronic acid eye drops taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day. Control Group Transcutaneous Auricular Vagus Nerve Stimulation taVNS device were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day. Control Group Hyaluronic acid eye drops taVNS device were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.
- Primary Outcome Measures
Name Time Method OSDI Baseline, month 1, 3, and 6 Ocular Surface Disease Index (OSDI) questionnaire: The OSDI questionnaire is designed to assess the severity of symptoms and the impact of ocular surface diseases, such as dry eye disease, on a patient's quality of life.
- Secondary Outcome Measures
Name Time Method TBUT Baseline, month 1, 3, and 6 Tear Breakup Time (TBUT): TBUT is a diagnostic test used to evaluate the stability of the tear film and diagnose dry eye disease. It measures the time it takes for dry spots to appear on the corneal surface after blinking while using a fluorescent dye. A shorter TBUT indicates less stable tear film, which is often associated with dry eye disease.
Schirmerl Baseline, month 1, 3, and 6 The Schirmer I test assesses tear production to diagnose dry eye syndrome. The length of the wetting is measured in millimeters. A lower measurement indicates reduced tear production, suggesting dry eye disease.
Corneal fluorescein staining (tCFS) Baseline, month 1, 3, and 6 tCFS used to assess the damage to the corneal epithelium, particularly in cases of dry eye disease, ocular surface disorders, or trauma.
Meibomian Gland Dysfunction Score Baseline, month 1, 3, and 6 MGD score used to assess the function of the Meibomian glands and the overall health of the eyelid margins.
Psychological status Baseline, month 3, 6 and 12 9-item Patient Health Questionnaire and Symptom Checklist-90 for anxiety are used to assess the psychological status.
Trial Locations
- Locations (2)
Beijing Tongren Hospital
🇨🇳Beijing, China
Wu Dong
🇨🇳Beijing, China