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Action of Intra-auricular Topical Lidocaine on Tinnitus

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05711641
Collaborator
(none)
33
Enrollment
1
Location
2
Arms
8.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine 10 MG/ML
  • Drug: Distilled water
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
All patients will receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized.All patients will receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized.
Masking:
Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose:
Diagnostic
Official Title:
Action of Intra-auricular Topical Lidocaine on Tinnitus
Actual Study Start Date :
Sep 2, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lidocaine 10%

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
Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.
Other Names:
  • Active substance

    		•
    Placebo Comparator: Placebo

    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
    Application of distilled water in the external auditory canal of tinnitus patients.
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Visual Analogue Scale Pontuation [Change in VAS pontuation from immediately before substance aplication at 5 minutes after.]

      escla 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.

    Secondary Outcome Measures

    1. Change in Tinnitus loudness [Change in tinnitus loudness from immediately before substance aplication at 5 minutes after.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculdade de Medicina da Universidade de São Paulo São Paulo Brazil 01246903

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital

    Investigators

    • Principal Investigator: Ricardo F Bento, University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ricardo Ferreira Bento, PhD, Professor of Otorhinolaringology Department of Faculdade de Medicina da Universidade de São Paulo, University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT05711641
    Other Study ID Numbers:
    • 5562868
    First Posted:
    Feb 3, 2023
    Last Update Posted:
    Feb 3, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ricardo Ferreira Bento, PhD, Professor of Otorhinolaringology Department of Faculdade de Medicina da Universidade de São Paulo, University of Sao Paulo General Hospital
    tinnitus
    lidocaine
    tinnitus treatment
    tinnitus diagnosis
    tinnitus suppression
    Additional relevant MeSH terms:
    Tinnitus
    Lidocaine

    Study Results

    No Results Posted as of Feb 3, 2023