Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Tinnitus Handicap Inventory
研究概览
简要总结
Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.
详细描述
In France, up to 16 million people suffer from tinnitus or ringing in the ears daily. This parasitic sound that does not come from the patient's environment can interfere with each individual in a variable way, sometimes creating an insurmountable handicap which has not known any effective treatment validated to date.
Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Patient over 18 years old.
- •Patient with disabling tonal tinnitus (THI score> 40) for more than 6 months.
- •Patient with a hearing loss of at least 25dB, centered on the frequency of tinnitus and requiring hearing aids
- •Patient who has never used a hearing aid or a tinnitus masking system.
- •Patient who stopped all tinnitus treatment at least 1 month before the start of the study (drug treatment, psychotherapy).
- •Patient being willing to attend all of the visits planned as part of the study.
- •Patient affiliated or beneficiary of a social security scheme.
- •Patient having signed the free and informed consent
排除标准
- •Minor patient.
- •Patient with hyperacusis
- •Patient already with a hearing aid or tinnitus masker.
- •Patient undergoing psychotropic or neurotropic drug treatments.
- •Patient with a history of psychological or psychiatric disorders.
- •Patient with a contraindication to wearing hearing aids.
- •Patient suffering from non-disabling tinnitus (THI score <40).
- •Patient suffering from intermittent, non-tonal or pulsatile tinnitus.
- •Patient participating in another clinical study.
- •Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision.
- •Pregnant or breastfeeding woman
结局指标
主要结局
Tinnitus Handicap Inventory
时间窗: 2 months
The primary endpoint is the score (out of 100 points) obtained on the Tinnitus Handicap Inventory (THI), expressed in terms of variation from the baseline.
次要结局
未报告次要终点