An interventional study of Treinamento Auditivo Musical and Placebo in Tinnitus, sponsored by Universidade Federal de Santa Maria. Recruiting at 2 sites in Brazil. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Universidade Federal de Santa Maria · Not applicable, Interventional, and Treatment
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Among 20 studies in Tinnitus with a site in Brazil — 1 open to participants now, 2 under way, none of them phase 3. Tinnitus · Brazil.
Among the 20 studies in Tinnitus with a site in Brazil, this one is the 16th largest by planned enrollment of the 16 interventional ones that give a count, is one of 4 that started in 2023, is one of 10 with no phase, and was the 15th registered.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
Browse Tinnitus studies →1 of the 20 studies in Tinnitus with a site in Brazil is open now.
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 49 Tinnitus studies recruiting now, 21 (43%) set no upper age limit and 18 (37%) stop at 75 or younger; 4 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 60 across 368 interventional studies indexed under Tinnitus.
Median enrollment 52 across the 16 interventional studies, 100 across the 4 observational. Of the 13 that completed or were terminated, 1 (8%) have results posted.
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2 of 20 have an industry lead sponsor. The 8 most frequent:
Universidade Federal de Santa Maria is the lead sponsor of 37 studies on the registry; 2 are open to participants now.
Universidade Federal de Santa Maria has 1 study filed under Tinnitus — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Tinnitus with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Treinamento Auditivo Musical
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.
Behavioral: Placebo
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.
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).
Changes in latency of the long latency auditory evoked potential (LLAEP)
Improve the latency in milliseconds of P2 potential
Time frame: Within a month
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Aug 2024, 17 months after the start.
Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 17 months is close to that.
Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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Universidade Federal de Santa Maria