NCT05291078已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 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.)
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 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)
- Changes in Pittsburg Sleep Quality Index (PSQI) score(baseline, 4 weeks)
研究者
研究点 (2)
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