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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in Tinnitus handicap inventory(THI) score
研究概览
简要总结
This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
Experimental Group A
Tinnitus patients(n=12 people)
干预措施: A transcutaneous trigeminal nerve stimulator: High Frequency (Device)
Experimental Group A
Tinnitus patients(n=12 people)
干预措施: Sound Therapy (Device)
Experimental Group B
Tinnitus patients(n=12 people)
干预措施: A transcutaneous trigeminal nerve stimulator: Low Frequency (Device)
Experimental Group B
Tinnitus patients(n=12 people)
干预措施: Sound Therapy (Device)
Control Group
Tinnitus patients(n=12 people)
干预措施: A transcutaneous trigeminal nerve stimulator: Sham (Device)
Control Group
Tinnitus patients(n=12 people)
干预措施: Sound Therapy (Device)
结局指标
主要结局
Changes in Tinnitus handicap inventory(THI) score
时间窗: 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.
次要结局
- Changes in EEG(baseline, 4 weeks)
- Changes in Pittsburg Sleep Quality Index (PSQI) score(baseline, 4 weeks)
- Changes in Loudness of Tinnitogram(baseline, 4 weeks)
- Changes in Minimal masking level of Tinnitogram(baseline, 4 weeks)
- Changes in Beck Depression Inventory(BDI) score(baseline, 4 weeks)
- Changes in Tinnitus magnitude index(TMI) score(baseline, 4 weeks)
- Changes in PPG(baseline, 4 weeks)
- Changes in MOS Short-Form 36-Item Health Survey(SF-36) score(baseline, 4 weeks)