Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.

Detailed Description
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Duration of study period (per participant): Screening period (-7 0 days), Intervention period (30 days) Patient needs to visit site at least 3 times (Screening, V1, V2). V1 can be done with screening visit. Tele-visit should be done on day 15.

Official Title
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Exploring the Effects of Transcutaneous Trigeminal Nerve Stimulation Using NUEYNE-T30 and NUEYNE-T100 and Sound Fusion Stimulation on Tinnitus: A Single-center, Double Blind, Placebo-controlled Group, Investigator Initiated Study (IIT) Study

Conditions
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Tinnitus

Intervention / Treatment
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* Device: A transcutaneous trigeminal nerve stimulator: High Frequency
* Device: A transcutaneous trigeminal nerve stimulator: Low Frequency
* Device: A transcutaneous trigeminal nerve stimulator: Sham
* Device: Sound Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults suffering from tinnitus Participants must be 19 to 70 years of age, at the time of screening Patient who suffers from tinnitus symptom more than 3 months and scores more than 18(criteria of mild) in Tinnitus Handicap Inventory (THI) examination Patients with a hearing threshold of 70dB or less when calculated using the quadrant method in the pure tone audiometry A person who has no physical or mental restrictions in participating in clinical trial Those who voluntarily agreed to participate in clinical trials A person who has no pregnancy plan and has agreed to the contraceptive plan for infertile women during the intervention period of clinical trial Exclusion Criteria: A person who does not meet the inclusion criteria A person who has difficulty communicating and conducting examinations. The disease of the outer or middle ear or central nervous system. Subjects who have difficulty conducting clinical trials due to intellectual or cognitive impairment Pregnant or lactating women A person who cannot understand or read ICF (illiterate or foreigner) A person who received tinnitus treatment (blood circulation enhancer, tranquilizer, tinnitus masker, biofeedback etc.) within 2 weeks of baseline or plans to receive it. A person who is difficult to participate in a clinical trial according to the researcher's judgment. (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head & neck. Patient suffering from unknown pain. Patients who are warned not to use out clinical trial device or is prohibited from using it.)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group A<br>Tinnitus patients(n=12 people) | Device: A transcutaneous trigeminal nerve stimulator: High Frequency<br>* 30min/day, at least 5 to 7 times a week<br>Device: Sound Therapy<br>* Notch Therapy at least 30min/day, at least 5 to 7 times a week<br>|
| Experimental: Experimental Group B<br>Tinnitus patients(n=12 people) | Device: A transcutaneous trigeminal nerve stimulator: Low Frequency<br>* 30min/day, at least 5 to 7 times a week<br>Device: Sound Therapy<br>* Notch Therapy at least 30min/day, at least 5 to 7 times a week<br>|
| Sham Comparator: Control Group<br>Tinnitus patients(n=12 people) | Device: A transcutaneous trigeminal nerve stimulator: Sham<br>* 30min/day, at least 5 to 7 times a week<br>Device: Sound Therapy<br>* Notch Therapy at least 30min/day, at least 5 to 7 times a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Tinnitus handicap inventory(THI) score | Check the changes in Tinnitus handicap inventory(THI) score The score on the questionnaire ranges from 0 to 100. Higher scores mean a worse outcome. | baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Loudness of Tinnitogram | Check the changes in Loudness of Tinnitogram | baseline, 4 weeks | 
| Changes in Minimal masking level of Tinnitogram | Check the changes in Minimal masking level of Tinnitogram | baseline, 4 weeks | 
| Changes in Tinnitus magnitude index(TMI) score | Check the changes in Tinnitus magnitude index(TMI) score The questionnaire consists of three questions. The score for No. 1 question ranges from 0 to 10. The score for No. 2 question ranges from 0% to 10%. The score for No. 2 question ranges from 0mm to 100mm. Higher scores mean a worse outcome. | baseline, 4 weeks | 
| Changes in EEG | Check the changes in EEG | baseline, 4 weeks | 
| Changes in PPG | Check the changes in PPG | baseline, 4 weeks | 
| Changes in Beck Depression Inventory(BDI) score | Check the changes in Beck Depression Inventory score The score on the questionnaire ranges from 0 to 63. Higher scores mean a worse outcome. | baseline, 4 weeks | 
| Changes in Pittsburg Sleep Quality Index (PSQI) score | Check the changes in Pittsburg Sleep Quality Index (PSQI) score The score on the questionnaire ranges from 0 to 21. Higher scores mean a worse outcome. | baseline, 4 weeks | 
| Changes in MOS Short-Form 36-Item Health Survey(SF-36) score | Check the changes in MOS Short-Form 36-Item Health Survey(SF-36) score The questionnaire consists of 8 subscales. The score for each subscale ranges from 0 to 100. Higher scores mean a better outcome. | baseline, 4 weeks |