Effect of Musical Auditory Training on Subjects With Tinnitus Disorder

NCT ID: NCT06371287

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2025-02-10

Brief 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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Group - Musical Auditory Training

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.

Group Type: EXPERIMENTAL

Treinamento Auditivo Musical

Intervention Type: 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.

Control Group - 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Christine Grellmann Schumacher

Investigator Official

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Christine Grellmann Schumacher G Schumacher

Role: CONTACT

christine.schumacher@acad.ufsm.br

553220-9362

Dayane Domeneghini Didoné D Didoné

Role: CONTACT

dayane.didone@ufsm.br

553220-9362

Facility Contacts

Dayane Domeneghini Didoné

Role: primary

dayane.didone@ufsm.br

553220-9362

Dayane D Didoné, Professora

Role: primary

dayane.didone@ufsm.br

553220-9362

Other Identifiers

64696022.1.0000.5346

Identifier Type: -

Identifier Source: org_study_id