Tinnitus, SubjectiveNCT05711641
Action of Intra-auricular Topical Lidocaine on Tinnitus
A study testing Lidocaine 10 MG/ML and Distilled water in people with Tinnitus, Subjective, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Lidocaine 10 MG/ML and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Sep 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina da Universidade de São Paulo
São Paulo, 01246903
About this study
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.
Read the 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- Lidocaine 10 MG/ML, Distilled water
- Keywords
- tinnitus, lidocaine, tinnitus treatment, tinnitus diagnosis, tinnitus suppression
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 10 MG/MLDrug
Also called Active substance
Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.
Distilled waterDrug
Also called Placebo
Application of distilled water in the external auditory canal of tinnitus patients.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately before and 5 minutes after receiving intervention on days 1 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start2 Sep 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Ferreira Bento, PhD, University of Sao Paulo General Hospital
- Investigators
- Ricardo F Bento, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711641
- Sponsor's protocol ID
- 5562868
- Status last verified
- Aug 2024
- First submitted
- 21 Jan 2023
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action of Intra-auricular Topical Lidocaine on Tinnitus
- ClinicalTrials.gov ID
- NCT05711641
- Acronym / sponsor ID
- 5562868
- Conditions
- Tinnitus, Subjective
- Keywords
- tinnitus, lidocaine, tinnitus treatment, tinnitus diagnosis, tinnitus suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 10% | Experimental | Drug: Lidocaine 10 MG/MLThe 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). |
| Placebo | Placebo comparator | Drug: Distilled waterThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months
Key exclusion criteria (6 listed)
- Otological infection
- Tympanic membrane perforation
- Anatomical alteration of the external ear
- Pulsatile tinnitus
- Objective tinnitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 10 MG/MLAlso: Active substanceApplication of 10% topical lidocaine in the external auditory canal of tinnitus patients. | Drug | Lidocaine 10% |
| Distilled waterAlso: PlaceboApplication of distilled water in the external auditory canal of tinnitus patients. | Drug | Placebo |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo F Bento principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 10 MG/ML and Distilled water in people with Tinnitus, Subjective, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale (VAS) Score (time frame: Immediately before and 5 minutes after receiving intervention on days 1 and 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.