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临床试验/NCT06371287
NCT06371287Unknown不适用

Effect of Musical Auditory Training on Neuroplasticity and Perception of Subjects With Tinnitus Disorder

Universidade Federal de Santa Maria1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
Changes in latency of the long latency auditory evoked potential (LLAEP)

研究概览

简要总结

Among the theories of tinnitus generation, there is that of central neuroplastic changes, which reports the association between changes and reorganization that occur in central auditory pathways and impacts on associated areas due to the altered neural signal. Auditory training modifies these altered pathways through auditory exercises, which provoke positive neuroplasticity. Musical auditory training is a proposal to stimulate auditory, cognitive and metalinguistic skills with activities focused on musicality. Therefore, the objective of this study is to verify the effect of musical auditory training (MAT) on the neuroplasticity of the auditory system and the perception of tinnitus disorder in young adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals of both sexes aged between 18 years and 55 years;
  • •Complaint of chronic tinnitus (minimum perception of six months) unilateral or bilateral;
  • •Hearing thresholds within normal limits bilaterally or even mild sensorineural hearing loss in the four-tone average (500, 1000, 2000 and 4000Hz);
  • •Annoyance score of at least four on the Visual Analogue Scale, considered a moderate symptom discomfort;
  • •Have normality in the Mini Mental State Examination (cognitive screening).

排除标准

  • •Apparent speech, psychiatric or neurological changes;
  • •History of head or brain trauma;
  • •Objective tinnitus (somatosensory and vascular);
  • •Present symptoms and/or diagnosis of middle ear involvement;
  • •Having started a new treatment (pharmacological or therapeutic) or having been diagnosed with a disease of any origin in the last month.
  • •Be carrying out another intervention for tinnitus during the research;
  • •Use of electronic assistive hearing devices.

研究组 & 干预措施

Study Group - Musical Auditory Training

Experimental

For musical training, the protocol proposed by Freire, et al. (2009). This protocol was created for elderly users of hearing aids and in this study it will be used as an instrument for intervention in tinnitus, aiming at auditory training through the hierarchization of auditory skills associated with musicality (FREIRE, 2009).

Eight sessions will be held over four weeks, two sessions per week. Sessions will last a minimum of 40 minutes and a maximum of 50 minutes. Victory supra-aural headphones will be used, connected to the computer. There will be calibration, with adjustment of the volume of sounds to the most comfortable level for the individual at the beginning of all sessions.

干预措施: Treinamento Auditivo Musical (Behavioral)

Control Group - Placebo

Placebo Comparator

Placebo sessions will also be held twice a week for four weeks, totaling eight sessions.

To ensure the same conditions for performing musical auditory training, in the placebo treatment, instrumental music will be used concomitantly with the exposure of films without sound, in which patients will be exposed to visual and auditory stimulation during the same time of EG intervention, at least 40 minutes and a maximum of 50 minutes.

干预措施: Placebo (Behavioral)

结局指标

主要结局

Changes in latency of the long latency auditory evoked potential (LLAEP)

时间窗: Within a month

Improve the latency in milliseconds of P2 potential

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Grellmann Schumacher

Investigator Official

Universidade Federal de Santa Maria

研究点 (1)

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