Effect of Musical Auditory Training on Subjects With Tinnitus Disorder

NCT06371287 — Not applicable, Unknown, 24 participants, Universidade Federal de Santa Maria

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

Registry	NCT06371287
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, sequential, masking: double, treatment
Enrollment	24 (Estimated)
Sponsor	Universidade Federal de Santa Maria (Other)
Conditions	Tinnitus
Interventions	Treinamento Auditivo Musical, Placebo (Behavioral)
Dates	start 2023-02-20, primary completion 2024-08-10 (estimated), completion 2025-02-10 (estimated), first posted 2024-04-17, last updated 2024-04-24
Locations	2 sites in Brazil

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Study Group - Musical Auditory Training	Experimental	Behavioral: Treinamento Auditivo Musical	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.
Control Group - Placebo	Placebo comparator	Behavioral: Placebo	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.

Treinamento Auditivo Musical (Behavioral): Auditory training with a focus on musicality. The skills trained will be: figure-ground for instrumental sounds, sequential figure-ground, directed listening, duration of sounds, frequency of sounds, rhythm (temporal structuring), auditory closure and audiovisual memory, with a focus on temporal processing, working memory and attention selective on an increasing scale of difficulty. The frequency ranges of instrumental sounds are from 200 to 4000 Hz, composed of the following instruments: guitar, vibraphone, piano, flute and drum.
Placebo (Behavioral): This placebo approach will be to demonstrate the influence of musical exposure without exercises with structuring auditory skills and compare with the TAM group. The song Sonata for two pianos in D major, K448, by Mozart, will be used. The films selected were: Cirque Du Soleil, entitled "The Journey of Man"; Chaplin collection with the following films: "Modern Times", "The Great Dictator", "In Search of Gold" and "Footlights". The choice of the order of the films will be random, as proposed by Freire (2009).

+Outcome measures

Primary outcomes

Changes in latency of the long latency auditory evoked potential (LLAEP) [Within a month]: Improve the latency in milliseconds of P2 potential

+Eligibility

Sex: All, ages: 18 Years to 55 Years

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

+Locations (2)

Facility	City	Country	Status
Universidade Federal de Santa Maria	Santa Maria, Rio Grande do Sul	Brazil	Recruiting
Universidade Federal de Santa Maria	Santa Maria, Rio Grande do Sul	Brazil	Recruiting