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Completed

NCT Number: NCT05711641

Action of Intra-auricular Topical Lidocaine on Tinnitus

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Medicina da Universidade de São Paulo

São Paulo, 01246903, Brazil

About this study

Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months are being evaluated. Exclusion criteria are: 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 All patients receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized. Only one ear receives the medications and side is defined by the higher intensity of tinnitus, or through draw in the case of symmetrical tinnitus.

The patient is instructed to lie in lateral decubitus, with the ear under study facing upwards and the substances are applied by filling the external auditory canal with lidocaine or distilled water for 5 min. Tinnitus intensity is measured (acuphenometry and VAS) before and after substance application and the variation is compared between lidocaine and placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Lidocaine 10 MG/ML

Drug

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

Other names: Active substance

distilled water

Drug

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

Other names: Placebo

Primary outcomes

  1. Change in Visual Analogue Scale (VAS) Score

    Time frame: 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.

  2. Change in Tinnitus Loudness

    Time frame: 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.

  3. Change in Minimum Masking Level (MML)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2023
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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