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The efficacy of low level Transcutaneous Electrical Nerve Stimulation of the ear in patients with chronic Tinnitus

The efficacy of Auricular Vagal Nerve Stimulation in patients with chronic Tinnitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9t8shp4
Enrollment
30
Registered
2026-07-23
Start date
2024-11-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus Otorhinolaryngologic Diseases

Interventions

This is a prospective, randomized, controlled, single-blind study. The sample will consist of 30 patients with chronic tinnitus. There will be three groups A, B, and C, which will be block-randomized

Sponsors

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals aged eighteen years or older; both genders; with chronic tinnitus for more than six months; unilateral or bilateral of sensorineural origin; who present with Anxiety and/or Depression, according to the patient health questionnaire; who obtain a score greater than four and or a general anxiety scale score greater than seven

Exclusion criteria

Exclusion criteria: Individuals with pathologies of the external and/or middle ear; with mixed or conductive hearing loss; chronic use of anticoagulants or hematological disorders; patients with bradycardia; who use a pacemaker; with schizophrenia; severe cognitive impairment

Design outcomes

Primary

MeasureTime frame
It´s expected difference of at least 20 points in the questionnaire between the moments before and after the intervention

Secondary

MeasureTime frame
A difference of at least two points on the visual analog scale is expected to be found between the period before and after the intervention;It is expected to identify with different application times of transcutaneous auricular vagal electrostimulation which will achieve the most significant improvement in depression symptoms according to the personal health questionnaire depression scale;It is expected to identify with different application times of transcutaneous auricular vagal electrostimulation which will achieve the most significant improvement in anxiety symptoms according to the anxiety disorder scale;It is expected to identify with different application times of transcutaneous auricular vagal electrostimulation which will achieve the most significant improvement in insomnia symptoms according to the insomnia severity index;Assess cognitive capacity before and after the application of transcutaneous auricular vagus nerve electrostimulation, using different application times, using vibrotactile somatosensory measures from the brain gauge

Countries

BR

Contacts

Public ContactRosana dos Santos

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

ros.seixassantos@hotmail.com+55(11)999895359

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026