NCT05711641

Action of Intra-auricular Topical Lidocaine on Tinnitus

Completed NA Results posted Last updated 30 August 2024

What this trial tests

NA trial testing Lidocaine 10 MG/ML in Tinnitus, Subjective in 32 participants. Completed in 1 June 2023.

Timeline

2 September 2022

Primary endpoint
1 June 2023

1 June 2023

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	diagnostic
Enrollment	32
Start date	2 September 2022
Primary completion	1 June 2023
Estimated completion	1 June 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Lidocaine 10 MG/ML — full drug profile →
• Distilled water — full drug profile →

Conditions studied

• Tinnitus, Subjective — all drugs for Tinnitus, Subjective →

Sponsor

University of Sao Paulo General Hospital

Who can join

18 and older, any sex, with Tinnitus, Subjective. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Visual Analogue Scale (VAS) Score Primary · Immediately before and 5 minutes after receiving intervention on days 1 and 15

scale ranging from 0 to 10 points used to measure the intensity of tinnitus, where zero corresponds to the absence of tinnitus perception and 10 corresponds to the largest volume that the patient imagines that tinnitus may have.

VAS before the application of the substances

Group	Value	95% CI
Lidocaine 10%	6.3	± 1.8
Placebo	6.3	± 2.0

VAS after the application of the substances

Group	Value	95% CI
Lidocaine 10%	5.5	± 2.1
Placebo	5.2	± 2.6

Change in Tinnitus Loudness Primary · Immediately before and 5 minutes after receiving intervention on days 1 and 15

Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure tinnitus intensity. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the tinnitus loudness is defined. Tinnitus loudness is measured in decibels and the higher the value found, the louder the tinnitus intensity.

Tinnitus loudness before application of substances

Group	Value	95% CI
Lidocaine 10%	7.2	± 7.8
Placebo	6.4	± 8.4

Tinnitus loudness after application of substances

Group	Value	95% CI
Lidocaine 10%	5.6	± 7.7
Placebo	4.6	± 8.3

Change in Minimum Masking Level (MML) Primary · Immediately before and 5 minutes after receiving intervention on days 1 and 15

Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure minimum masking level. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the minimum stimulus that masks tinnitus is determined. The minimum masking level is the intensity that an external sound must have to cover up tinnitus until it is no longer perceived by the patient. MML is measured in decibels. The lower the MML value, the more easily tinnitus can be masked, suggesting a lower degree of discomfort for the patient.

MML before the application of the substances

Group	Value	95% CI
Lidocaine 10%	4	± 3
Placebo	4.8	± 2.4

MML after the application of the substances

Group	Value	95% CI
Lidocaine 10%	3.7	± 2.9
Placebo	3.8	± 2.2

Sponsor's own description

The main objective of this clinical trial placebo controled is to evaluate the action of intraauricular topical lidocaine on tinnitus.

The question to be answered is whether lidocaine is superior to placebo (distilled water) in reducing tinnitus intensity when applied topically within the external auditory canal.

Tinnitus intensity will be measured using the visual analog scale and acuphenometry before and after lidocaine or placebo application.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Topical Intra-Auricular Lidocaine on Tinnitus: A Randomized Double-Blind Placebo-Controlled Study.
   Campos TV, Bento RF, Oticica J, Jabour MS, et al · · 2025 · PMID 41113752 · DOI 10.1055/s-0045-1810028