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临床试验/NCT05884879
NCT05884879招募中不适用

Assessment of Listening Effort in Tinnitus Patients

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Listening effort

研究概览

简要总结

About 5-15% of the general population experience a chronic ringing, buzzing, hissing or roaring sound in one or two ears, without any external source. This so-called tinnitus can be present in people with normal hearing, but often coexists with hearing loss. Most people suffering from tinnitus can cope with it, however a minority experiences emotional distress or cognitive dysfunction as a result of the tinnitus, called tinnitus disorder. People suffering from tinnitus disorder regularly complain about an increased experienced effort when listening to speech or other sounds in daily life situations. As this has never been proven scientifically, the investigators aim to evaluate the effect of the tinnitus percept and tinnitus disorder on experienced listening effort by comparing listening effort between a population with tinnitus disorder and a population without tinnitus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Young adults, i.e. 18-69 year old;
  • Pure tone average <35 dB HL (0.5, 1, 2, 4 kHz);
  • Proficient and native speaker of Dutch language;
  • TINNITUS GROUP: Severe unilateral or bilateral tinnitus disorder (TQ > 46).
  • CONTROL GROUP: No tinnitus.

排除标准

  • Significant asymmetric hearing loss: |PTAright - PTAleft| > 15 dB (PTA = pure tone average of 500, 1000, 2000 and 4000 Hz);
  • Significant loss of vision (text on screen at 70 cm should be readable);
  • Frequent user of any of the following devices: Hearing Aid, Bone Conduction Device, Cochlear Implant, Tinnitus Masker;
  • Additional mental or physical disabilities that may prevent active participation and testing as per protocol.

结局指标

主要结局

Listening effort

时间窗: 1 day

Subjective listening effort as a function of the speech reception threshold (SRT)

次要结局

  • Listening effort predictability of tinnitus related questionnaire: TFI(1 day)
  • Listening effort predictability of tinnitus related questionnaire: TQ(1 day)
  • Listening effort predictability of tinnitus related questionnaire: HADS(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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