NCT04623957Unknown不适用
Safety and Efficacy of Acupressure Applied Through ForgTin© in Patients With Tinnitus
Pansatori GmbH0 个研究点目标入组 35 人开始时间: 2020年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 主要终点
- Tinnitus Handicap Inventory
研究概览
简要总结
The main objective of this clinical trial is to evaluate the effectiveness and safety of the medical product ForgTin with regard to the impairment and change in the sensation of tinnitus (volume, frequency, psychological stress).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and female patients (aged > 18 years)
- •Subjective tinnitus in one or both ears with intermittent or continuous symptoms with a duration of > 6 months
- •Tinnitus of Grade II, III or IV according to Mini-Tinnitus-Questionnaire (Mini-TF12):
- •Grade II (score of 8-12): moderately distressed
- •Grade III (score of 13-18): severely distressed
- •Grade III (score of 19-24): most severely distressed
- •If a drug therapy with psychoactive substances (e.g. antidepressants, anticonvulsants) exists at the beginning of the therapeutic intervention, it must have been stable for at least 30 days. The therapy should remain constant during the duration of the study, but a necessary change is not an exclusion criterion. Any change in medication is documented in the CRF.
- •Provides written informed consent
排除标准
- •Vestibular schwannoma (acoustic neuroma)
- •Objective tinnitus
- •Any other tinnitus-related treatment
- •Ménière's Disease
- •Acute infections of the hearing system (acute otitis media, otitis externa, acute sinusitis)
- •Acute infections (acute otitis media, otitis externa, acute sinusitis)
- •Hearing aids or Cochlear Implants (CI)
- •Any current treatment with anticonvulsants, cortisone, tricyclic antidepressants
- •Other lesions (glomus tumors, meningiomas, adenomas, vascular lesions or neuro-vascular conflicts) detected by clinical assessment
- •Serious, concomitant disorder, including major depression, anxiety
- •Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives
- •Inability to comply with the protocol requirements
结局指标
主要结局
Tinnitus Handicap Inventory
时间窗: Change of the Tinnitus Handicap Inventory assessed at Day 0, Month 3, Month 4, Month 7
Tinnitus Impairment as assessed by the Tinnitus Handicap Inventory (THI)
次要结局
未报告次要终点
研究者
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