Effect of Musical Auditory Training on Subjects With Tinnitus Disorder

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371287
• Other study ID #: 64696022.1.0000.5346
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: February 10, 2025

Study information

• Verified date: April 2024
• Source: Universidade Federal de Santa Maria
• Contact: Christine Grellmann Schumacher G Schumacher
• Phone: 553220-9362
• Email: christine.schumacher[@]acad.ufsm.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 10, 2025
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Treinamento Auditivo Musical
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
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).

Locations

Country	Name	City	State
Brazil	Universidade Federal de Santa Maria	Santa Maria	RS
Brazil	Universidade Federal de Santa Maria	Santa Maria	RS

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in latency of the long latency auditory evoked potential (LLAEP)	Improve the latency in milliseconds of P2 potential	Within a month