Tinnitus
Conditions
Brief summary
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
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.
Interventions
DEVICEA transcutaneous trigeminal nerve stimulator: High Frequency
30min/day, at least 5 to 7 times a week
DEVICEA transcutaneous trigeminal nerve stimulator: Low Frequency
30min/day, at least 5 to 7 times a week
DEVICEA transcutaneous trigeminal nerve stimulator: Sham
30min/day, at least 5 to 7 times a week
DEVICESound Therapy
Notch Therapy at least 30min/day, at least 5 to 7 times a week
Sponsors
Nu Eyne Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Tinnitus handicap inventory(THI) score | baseline, 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Minimal masking level of Tinnitogram | baseline, 4 weeks | Check the changes in Minimal masking level of Tinnitogram |
| Changes in Tinnitus magnitude index(TMI) score | baseline, 4 weeks | 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. |
| Changes in EEG | baseline, 4 weeks | Check the changes in EEG |
| Changes in Loudness of Tinnitogram | baseline, 4 weeks | Check the changes in Loudness of Tinnitogram |
| Changes in Beck Depression Inventory(BDI) score | baseline, 4 weeks | Check the changes in Beck Depression Inventory score The score on the questionnaire ranges from 0 to 63. Higher scores mean a worse outcome. |
| Changes in Pittsburg Sleep Quality Index (PSQI) score | baseline, 4 weeks | 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. |
| Changes in MOS Short-Form 36-Item Health Survey(SF-36) score | baseline, 4 weeks | 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. |
| Changes in PPG | baseline, 4 weeks | Check the changes in PPG |
Countries
South Korea
Outcome results
None listed