Tinnitus
Conditions
Interventions
This is an intervention study linked to the parent project approved by the Brazilian Registry of Clinical Trials (ReBEC - RBR-5s76ksq). In this derivative project, to be carried out at the Neurorehabi
active group"
with vagal auricular stimulation (n=12) and a "
sham group"
(n=12) in a randomized manner. Participant allocation will be performed by simple randomization and will be generated by GoogleSheet® software and exported in an immutable format. Predictable allocati
they must have consented to participate through the Informed Consent Form
they must have a diagnosis of temporomandibular dysfunction according to the Diagnostic Criteria
they must present an alteration in heart rate variability (sympathetic or parasympathetic index) outside the normal range (-1 to 1), in at least 2 of the 3 moments of the orthotest
and they must have a complaint of somatosensory tinnitus. Individuals with neurological, cognitive, or linguistic impairment
non-users of the oral linguistic code
those with tonal and vocal audiometry outside the normal limits
individuals with rheumatological diseases such as rheumatoid arthritis and ankylosing spondylitis
with cardiac arrhythmia
Sponsors
Centro de Ciências da Saúde da Universidade Federal do Espírito Santo
Universidade Federal do Espírito Santo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged 18 years or older, of both genders, with temporomandibular dysfunction according to the Diagnostic Criteria, with alterations in heart rate variability in at least 2 of the 3 time points of the orthotest, and with somatosensory tinnitus
Exclusion criteria
Exclusion criteria: Individuals with neurological, cognitive, or linguistic impairments will be excluded from the study; those who do not use the oral language code; those with tonal and vocal audiometry outside the normal limits; individuals with rheumatological diseases such as rheumatoid arthritis and ankylosing spondylitis; those with cardiac arrhythmia or other cardiovascular conditions using beta-blockers; pregnant women or women in the puerperium or postpartum period; patients diagnosed with cancer, epilepsy, skull, cervical or rib fractures, and severe osteoporosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An improvement in quality of life, anxiety, depression, and stress caused by somatosensory tinnitus is expected after all vagal auricular stimulation sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| There is no secondary outcome | — |
Countries
Brazil
Contacts
Public ContactCarolina Comarela
Universidade Federal do Espírito Santo
Outcome results
None listed