Treatment for Hearing Loss, Cochlear

Phase-Based Estimates
1
Effectiveness
1
Safety
Our Lady of the Lake Hospital, Baton Rouge, LA
Hearing Loss, Cochlear+4 More
Eligibility
18+
All Sexes
Eligible conditions
Hearing Loss, Cochlear

Study Summary

This study is evaluating whether topical tetracaine drops are as effective as topical phenol for local anesthesia for intratympanic steroid injections.

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Eligible Conditions

  • Hearing Loss, Cochlear
  • Hearing Loss, Sensorineural
  • Hearing Loss
  • Vertigo, Aural
  • Intratympanic Steroid Injection
  • Hearing Loss, Idiopathic Sudden Sensorineural
  • Meniere Disease

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Hearing Loss, Cochlear. Measurement will happen over the course of Immediately following the procedure to 6 months from procedure.

Month 6
Difference in Pain Score
Statistical difference in tympanic membrane perforation presence or absence after the steroid injection procedure when using either tetracaine or phenol as the local anesthetic

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Phenol

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Phenol
Drug
Patients will be positioned in supine position and tympanic membrane visualized with operative microscope. Phenol applicator will be used to topically apply 90% phenol to the injection site (posterior/Inferior aspect of tympanic membrane).
Tetracaine
Drug
Patients will be positioned in supine position at this time 0.5% tetracaine drops will be used to fill the ear canal. Tetracaine will then be allowed to stay in place for approximately 10 to 15 minutes with the patient's head positioned with affected ear up. After this, using an operative microscope the drops will be removed from the ear canal with suction.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately following the procedure to 6 months from procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediately following the procedure to 6 months from procedure for reporting.

Who is running the study

Principal Investigator
L. S.
Leslie Son, Academic Research Director
Our Lady of the Lake Hospital

Closest Location

Our Lady of the Lake Hospital - Baton Rouge, LA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People aged 18 or over are called adult subjects. show original
The person has a sudden hearing loss that doctors can't explain and might have Meniere's disease, which is a problem with the balance organ in the inner ear. show original
The care plan includes treatment with intratympanic steroid injection. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is treatment?

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The presence of hearing loss and comorbid bipolar disorder both significantly reduce the use of different types of medical care, including pharmaceuticals. The role of hearing losses in CVR was not confirmed.

Unverified Answer

What is the average age someone gets hearing loss, cochlear?

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The mean age of hearing loss onset was 45.8 years with a range from 18 to 75 years. The prevalence of hearing loss on one ear ranged from 10 to 53%. All mean levels were higher in the left ear (p<0.05). On the prevalence of unilateral hearing loss on one or both ears, there was no difference between the genders.

Unverified Answer

What is hearing loss, cochlear?

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Hearing loss exists on our planet, affecting our ability to communicate and live life with dignity. The auditory system is designed to detect, process and transmit sound signals. People with hearing loss can be exposed to many situations where it can be problematic to communicate. However, hearing loss alone does not necessarily equate to problems, such as poor communication skills. Hearing problems can be caused by a number of different reasons, and they can vary in severity. Problems can arise not just due to the ear, but also related things such as a background noise and reverberation. Problems may be aggravated by a chronic illness. Hearing loss can be classified by the cause.

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What are the signs of hearing loss, cochlear?

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The signs of hearing loss are loud ringing, high pitches as the noise reaches our ears, and inability to hear the softer words spoken by others. The signs of cochlear include an inability to hear speech or music and a distorted sense of hearing. The most common signs of hearing loss and of cochlear damage are the inability to hear speech and music or a distorted sense of hearing. All the signs of hearing loss must be assessed to prevent the deaf-hearing-impaired person from being admitted to the hospital to the risk of unnecessary ear surgery.

Unverified Answer

What causes hearing loss, cochlear?

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A number of factors can result in hearing loss and it is not the result of any single factor alone or in combination. Risk factors include ototoxic agents and noise. Many hearing-loss treatments work by stopping these risk factors.

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Can hearing loss, cochlear be cured?

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Cochlear implantation can be a useful long-term method to treat high frequencies hearing loss. However, due to the limited number of patients who can enjoy full hearing recovery it is not an ideal treatment to cure high frequency hearing loss.

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How many people get hearing loss, cochlear a year in the United States?

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In this national sample most individuals have no prior history of diagnosed hearing loss. Although the number of new diagnoses is still low, their impact on quality of life and ability to perform daily activities should be considered in population-based screenings.

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What are common treatments for hearing loss, cochlear?

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The common treatments for hearing loss include speech therapy, and hearing aids. In some cases, surgeries are performed, most commonly in the case of cochlear loss. Cochlear implants are often performed, but usually only to recipients with cochlea losses that cannot be rehabilitated through audiometry or other non-implanted means.

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What is the latest research for hearing loss, cochlear?

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The two most popular prevention methods are [music therapy and noise control; however, there is currently a lack of high-quality studies to support music therapy or noise control as a treatment for hearing loss] (https://www.ncbi.nlm.nih.gov/books/NBK155522). Additionally, [noise control is ineffective in preventing tinnitus and is recommended only in addition to hearing aid use in moderate- to high-sensitivity [noise control or avoidance, or use of hearing protectors are recommended in those with moderate to severe high-frequency hearing loss in both ears] (https://www.fisher.edu/med/prevention/Hearing_Loss.

Unverified Answer

What are the common side effects of treatment?

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The most common side effects experienced by the patients in our study were headache, itch, and abdominal discomfort. The prevalence was similar to those reported in the literature. This trial is registered at clinicaltrials.gov (ClinicalTrials.gov; registered September 14, 2020; NCT03394944).

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How serious can hearing loss, cochlear be?

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HL is an important issue for both audiometric test scores and psychological well-being, and it causes a range of socio-economic effects and losses to productivity. Hearing loss may have far-reaching, but seldom serious financial effects for individual patients, but it has important implications for communities, workplaces and educational systems. There are three types of hearing loss, namely sensorineural (nerve hearing), conductive (sound waves going through the ear canal or round window into the middle ear) and mixed (both nerve and conductive hearing loss). Sensorineural hearing loss is the most common and causes difficulties of understanding speech and in particular people who are hard of hearing.

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Who should consider clinical trials for hearing loss, cochlear?

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In this population, it is not possible to determine if there is a correlation between hearing loss and the risk of developing MM. Clinical trials to evaluate MM treatments for hearing loss are needed. Data from a recent study has potential to identify candidates for future trial(s) in order to develop a strategy for evaluating and treating candidates with a hearing loss and cochlear impairment.

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