TinnitusNCT06371287
Effect of Musical Auditory Training on Subjects With Tinnitus Disorder
A study testing Treinamento Auditivo Musical in people with Tinnitus, run by Universidade Federal de Santa Maria at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Treinamento Auditivo Musical
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Feb 2023to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul, 97.105-970
Dayane Domeneghini Didoné, 553220-9362, dayane.didone@ufsm.br
Dayane Domeneghini Didoné D Dayane Domeneghini Didoné
- Recruiting
Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul, 97.105-970
Dayane D Didoné, Professora, 553220-9362, dayane.didone@ufsm.br
Christine G Schumacher, Mestranda
About this study
Official title: Effect of Musical Auditory Training on Neuroplasticity and Perception of Subjects With Tinnitus Disorder
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
- Being tested
- Treinamento Auditivo Musical, Placebo
- Keywords
- Plasticidade Neuronal, Zumbido, Processamento Auditivo Central
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treinamento Auditivo MusicalBehavioural
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.
PlaceboBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Treinamento Auditivo Musical |
| 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. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in latency of the long latency auditory evoked potential (LLAEP)
Improve the latency in milliseconds of P2 potential
Measured: Within a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start20 Feb 2023
- Primary completion10 Aug 2024 (estimated)
- Study completion10 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Grellmann Schumacher, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371287
- Sponsor's protocol ID
- 64696022.1.0000.5346
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Musical Auditory Training on Neuroplasticity and Perception of Subjects With Tinnitus Disorder
- ClinicalTrials.gov ID
- NCT06371287
- Acronym / sponsor ID
- 64696022.1.0000.5346
- Conditions
- Tinnitus
- Keywords
- Plasticidade Neuronal, Zumbido, Processamento Auditivo Central
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group - Musical Auditory Training | Experimental | Behavioral: Treinamento Auditivo MusicalFor 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: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treinamento Auditivo MusicalAuditory 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. | Behavioural | Study Group - Musical Auditory Training |
| PlaceboThis 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). | Behavioural | Control Group - Placebo |
Primary outcome
Changes in latency of the long latency auditory evoked potential (LLAEP)
Time frame: Within a month
Improve the latency in milliseconds of P2 potential
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treinamento Auditivo Musical in people with Tinnitus, run by Universidade Federal de Santa Maria at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Grellmann Schumacher G Schumacher (553220-9362, christine.schumacher@acad.ufsm.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in latency of the long latency auditory evoked potential (LLAEP) (time frame: Within a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.