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Action of Intra-auricular Topical Lidocaine on Tinnitus

Primary Purpose

Tinnitus, Subjective

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine 10 MG/ML
Distilled water
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tinnitus, Subjective focused on measuring tinnitus, lidocaine, tinnitus treatment, tinnitus diagnosis, tinnitus suppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine 10%

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in Visual Analogue Scale Pontuation
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

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.

Full Information

First Posted
January 21, 2023
Last Updated
June 26, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05711641
Brief Title
Action of Intra-auricular Topical Lidocaine on Tinnitus
Official Title
Action of Intra-auricular Topical Lidocaine on Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
Keywords
tinnitus, lidocaine, tinnitus treatment, tinnitus diagnosis, tinnitus suppression

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine 10%
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Lidocaine 10 MG/ML
Other Intervention Name(s)
Active substance
Intervention Description
Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.
Intervention Type
Drug
Intervention Name(s)
Distilled water
Other Intervention Name(s)
Placebo
Intervention Description
Application of distilled water in the external auditory canal of tinnitus patients.
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale Pontuation
Description
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.
Time Frame
Change in VAS pontuation from immediately before substance aplication at 5 minutes after.
Secondary Outcome Measure Information:
Title
Change in Tinnitus loudness
Description
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.
Time Frame
Change in tinnitus loudness from immediately before substance aplication at 5 minutes after.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo F Bento
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

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Action of Intra-auricular Topical Lidocaine on Tinnitus

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