Action of Intra-auricular Topical Lidocaine on Tinnitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05711641|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2023
Last Update Posted : May 10, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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|
|Tinnitus, Subjective||Drug: Lidocaine 10 MG/ML Drug: Distilled water||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|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.|
|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.|
|Official Title:||Action of Intra-auricular Topical Lidocaine on Tinnitus|
|Actual Study Start Date :||September 2, 2022|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
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 Name: 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 Name: Placebo
- Change in Visual Analogue Scale Pontuation [ Time Frame: 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.
- Change in Tinnitus loudness [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05711641
|Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, Brazil, 01246903|
|Principal Investigator:||Ricardo F Bento||University of Sao Paulo|
|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|
|Other Study ID Numbers:||
|First Posted:||February 3, 2023 Key Record Dates|
|Last Update Posted:||May 10, 2023|
|Last Verified:||May 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|
Nervous System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action