Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

NCT06696625 | Recruiting

• 1 other identifier: DED_taVNS_2024
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease. Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Conditions

Dry Eye Disease

Keywords

taVNS; Dry eye; RCT

Outcome Measures

Primary Outcomes (1)

• OSDI

  The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eye (33-100).

  Baseline, month 1, 3, and 6

Secondary Outcomes (6)

• TBUT

  Baseline, month 1, 3, and 6

• Schirmer

  Baseline, month 1, 3, and 6

• CFS

  Baseline, month 1, 3, and 6

• DEQ-5

  Baseline, month 1, 3, and 6

• PHQ-9

  Baseline, month 1, 3, and 6

Study Arms (2)

taVNS group

EXPERIMENTAL

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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation; Drug: 0.1% sodium hyaluronate eye drop

Control Group

SHAM COMPARATOR

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. Patients in control group 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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation; Drug: 0.1% sodium hyaluronate eye drop

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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.

Control Group; taVNS group

0.1% sodium hyaluronate eye drop DRUG

Participants received 0.1% sodium hyaluronate eye drop (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany).

Control Group; taVNS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 and Age \<=65.
• complaint of DED symptoms for 6 months or longer at screening.
• ocular surface disease index (OSDI) score of 25 or higher.
• tear film breakup time (TFBUT) of 5 seconds or less.
• Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
• tCFS score of 4 or higher.

You may not qualify if:

• History systemic autoimmune diseases and ocular/periocular malignancy.
• Clinically relevant slitlamp findings or abnormal lid anatomy.
• Active ocular allergies and active infection.
• Pregnant or lactating women.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

China Beijing TongRen Hospital, Capital Medical University Beijing, China

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Dong Wu, Doctor

CONTACT

8613810988682; wudong0120@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: July 1, 2021
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)