A Randomized, Single-blind, Controlled Trial to Evaluate the Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Turkish version of the Tinnitus Disability Questionnaire (THI)
研究概览
简要总结
A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus.
The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.
详细描述
All patients with normal otologic examinations and a type A tympanogram will be included in the study. Those who meet the exclusion criteria will not be included in the study, and patients will be randomized. Subsequently, the groups will be divided into two groups: those who will receive only medical treatment and those who will receive neural therapy in addition to medical treatment. Patients will be administered tinnitus severity questionnaires based on the SF-12 (short form) and the VAS (visual analog scale), the Turkish adaptation of the Tinnitus Disability Inventory (THI). The same questionnaires will be administered at their follow-up visits three months later.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a type A tympanogram in the tympanogram of all cases with normal otological examinations (air-bone gap should not be observed in any case).
排除标准
- •Patients with a disease that may cause objective tinnitus,
- •Otosclerosis,
- •Chronic otitis media,
- •Acoustic tumor,
- •Meniere's disease,
- •History of ear surgery or head trauma, and those with neuropsychiatric diseases.
- •Patients who have had ear surgery,
- •Permanent hearing loss (total),
- •Severe cardiovascular system failure, uncontrolled arrhythmia,
- •Severe renal failure, or liver failure
研究组 & 干预措施
Treatment Group
干预措施: Neural Therapy of Huneke (Procedure)
Control Group
干预措施: Betahistine 24 mg bid (Betaserc) (Drug)
结局指标
主要结局
Turkish version of the Tinnitus Disability Questionnaire (THI)
时间窗: 3 months
SF-12 (short form)
时间窗: 3 months
Tinnitus severity according to VAS (visual analog scale)
时间窗: 3 months
次要结局
未报告次要终点
研究者
Roza Jizel Dagdelen MD
Medical Doctor , Assistant Researcher
Sisli Hamidiye Etfal Training and Research Hospital