Action of Intra-auricular Topical Lidocaine on Tinnitus

NCT05711641 | Completed Results

• 1 other identifier: 5562868
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tinnitus, Subjective

Keywords

tinnitus; lidocaine; tinnitus treatment; tinnitus diagnosis; tinnitus suppression

Outcome Measures

Primary Outcomes (3)

• Change in Visual Analogue Scale (VAS) Score

  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.

  Immediately before and 5 minutes after receiving intervention on days 1 and 15

• Change in Tinnitus Loudness

  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.

  Immediately before and 5 minutes after receiving intervention on days 1 and 15

• Change in Minimum Masking Level (MML)

  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.

  Immediately before and 5 minutes after receiving intervention on days 1 and 15

Study Arms (2)

Lidocaine 10%

EXPERIMENTAL

The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and 10% lidocaine is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).

Drug: Lidocaine 10 MG/ML

Placebo

PLACEBO COMPARATOR

The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and distilled water is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).

Drug: Distilled water

Interventions

Lidocaine 10 MG/ML DRUG

Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.

Also known as: Active substance

Lidocaine 10%

Distilled water DRUG

Application of distilled water in the external auditory canal of tinnitus patients.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months

You may not qualify if:

• Otological infection
• Tympanic membrane perforation
• Anatomical alteration of the external ear
• Pulsatile tinnitus
• Objective tinnitus
• Known allergy to lidocaine or other topical anesthetic and pregnancy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Lidocaine; compact-colony-forming active substance

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Tatiane Vacaro Campos
• Organization: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

tati_vacaro@hotmail.com

+551126617585

Study Officials

• Ricardo F Bento

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double blind study. The substances are produced by the same handling pharmacy and delivered in identical vials, only with the information: substance 1 and substance 2.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otorhinolaringology Department of Faculdade de Medicina da Universidade de São Paulo

Model Details: All patients will receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized.

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: February 3, 2023
• Study Start: September 2, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Locations

BR (1)