Efficacy and Safety of the Soricle, a Class III Combination Device of Vagus Nerve Stimulation and Sound Stimulation, for Subjective Tinnitus Relief: A Prospective, Single-Center, Randomized, Double-Blind, Sham-Controlled, Exploratory Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Tinnitus Handicap Inventory (THI) Score
研究概览
简要总结
This study was conducted to evaluate the efficacy and safety of Soricle, a medical device combining transcutaneous vagus nerve stimulation and sound stimulation, in patients with subjective tinnitus.
Participants were randomly assigned to either the active treatment group or a sham control group in a double-blind manner. The device was used daily for 8 weeks.
The primary objective was to assess the improvement in tinnitus symptoms, and safety was evaluated throughout the study period.
详细描述
This was a prospective, single-center, randomized, double-blind, sham-controlled exploratory clinical trial designed to evaluate the efficacy and safety of Soricle, a Class III medical device combining transcutaneous vagus nerve stimulation (tVNS) and sound stimulation, for the treatment of subjective tinnitus.
Participants diagnosed with subjective tinnitus were randomly assigned in a 1:1 ratio to either the active treatment group or the sham control group. The investigational device was applied daily for 8 weeks.
The primary objective of the study was to evaluate the improvement in tinnitus symptoms, and secondary objectives included additional efficacy assessments and safety evaluations. Safety was monitored throughout the study, including the assessment of adverse events.
The study was conducted in accordance with ICH-GCP guidelines and was approved by the Institutional Review Board. All participants provided written informed consent prior to participation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study was conducted in a double-blind manner. Participants, investigators, care providers, and outcome assessors were blinded to group assignments. The active device and sham device were identical in appearance to maintain blinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Patients with subjective tinnitus
- •Able to understand and provide informed consent
- •Willing to comply with study procedures
排除标准
- •Objective tinnitus
- •Severe hearing loss requiring immediate treatment
- •History of neurological or psychiatric disorders that may affect study outcomes
- •Use of other tinnitus treatments during the study period
- •Any condition that, in the investigator's judgment, may interfere with study participation
研究组 & 干预措施
Sham Comparator
Participants received a sham device identical in appearance to the active device but without delivering therapeutic stimulation.
干预措施: Sham Device (Device)
tVNS Stimulation
Participants received transcutaneous vagus nerve stimulation (tVNS) using the investigational device.
干预措施: tVNS Device (Device)
tVNS + Sound Stimulation
Participants received combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation using the investigational device.
干预措施: tVNS + Sound Stimulation Device (Device)
结局指标
主要结局
Change in Tinnitus Handicap Inventory (THI) Score
时间窗: 8 weeks
The change in Tinnitus Handicap Inventory (THI) score from baseline to 8 weeks was assessed to evaluate the effectiveness of the intervention.
次要结局
未报告次要终点