100 Participants Needed

Oral Statins for Hearing Loss

DW
Overseen ByDonna Whitlon, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Northwestern University
Must be taking: Oral steroids
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether adding an oral statin (a cholesterol-lowering drug) to the usual treatment can improve outcomes for individuals with sudden hearing loss in one ear. Participants will receive either the statin or a placebo alongside standard medications to evaluate improvements in hearing and speech understanding. The trial targets individuals who have recently experienced sudden hearing loss in one ear and have no history of similar events. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used statins in the last 12 months or have had oral steroid treatment in the last 30 days. It's best to discuss your current medications with the trial team.

What is the safety track record for these treatments?

Studies have shown that statins, drugs commonly used to lower cholesterol, might also help protect hearing. Some research suggests that statins can reduce hearing loss and tinnitus in certain cases, though not all studies agree. Some individuals have noticed changes in their hearing after using statins for several months.

While statins are generally safe, they can cause side effects, including muscle pain, liver problems, and digestive issues. Many people use statins safely, especially under a doctor's supervision.

This trial tests statins alongside usual treatments for sudden hearing loss. Since statins are already approved for other uses, their safety is well established. However, everyone reacts differently to medications, so participants in the trial will be closely monitored for any side effects.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for hearing loss, which often involve hearing aids or cochlear implants, this investigational treatment combines a statin with methylprednisolone. Researchers are excited about this approach because statins, typically used to lower cholesterol, might improve blood flow to the inner ear, potentially enhancing hearing recovery. Additionally, the use of oral statins alongside methylprednisolone could offer a less invasive option compared to traditional methods. This novel combination targets the underlying causes of hearing loss, offering hope for more effective and quicker recovery.

What evidence suggests that this trial's treatments could be effective for hearing loss?

Research has shown that statins might help with hearing problems. A survey found that people taking statins had a lower risk of hearing issues. Other studies suggest that statins could reduce the risk of sudden hearing loss and ringing in the ears, especially for individuals with conditions like diabetes. Animal studies indicate that statins might protect against hearing damage. In this trial, one group of participants will receive a combination of methylprednisolone and statins to evaluate their potential benefits for hearing health. Overall, evidence suggests that statins could benefit hearing health.35678

Who Is on the Research Team?

DW

Donna Whitlon, Ph.D.

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Adults aged 18-80 with sudden one-sided hearing loss, diagnosed within the first two weeks of symptoms. Participants must have a significant level of hearing loss and be fluent in English. Excluded are those with prior similar events, certain diseases (like diabetes or severe neurological conditions), history of substance abuse, recent steroid use, ear anomalies, or who've taken statins or ototoxic drugs recently.

Inclusion Criteria

Your average hearing loss is 30 decibels or more across three specific frequencies.
I speak and understand English very well.
Seen in the clinic within the first 14 days after the onset of symptoms
See 2 more

Exclusion Criteria

You are allergic or sensitive to any parts of the study medication.
I have taken statins in the past year.
I have a genetic condition that affects my hearing.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive oral methylprednisolone and either a statin or placebo for 7 days, with potential intratympanic dexamethasone if no improvement after 2 weeks

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hearing tests and tinnitus evaluation

up to 4 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • dexamethasone
  • methylprednisolone
  • Placebo
  • Statin
Trial Overview The trial is testing if adding an oral statin to standard treatment for sudden sensorineural hearing loss improves outcomes. Standard treatment includes methylprednisolone and intratympanic dexamethasone as salvage therapy. Hearing improvement and tinnitus will be measured.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: StatinExperimental Treatment3 Interventions
Group II: PlaceboPlacebo Group3 Interventions

dexamethasone is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Decadron for:
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Approved in European Union as Dexamethasone for:
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Approved in Canada as Dexamethasone for:
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Approved in Japan as Dexamethasone for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Published Research Related to This Trial

A 68-year-old male patient with inner ear inflammation and chronic sinusitis experienced significant improvement in hearing loss and sinus symptoms after switching from oral steroids to topical betamethasone, highlighting a potential alternative treatment for those with adverse reactions to systemic steroids.
Audiometry results showed a notable recovery in hearing, with improvements from 50 dB to 20 dB in the right ear and from 70 dB to 35 dB in the left ear, suggesting that topical steroid therapy can effectively address inner ear conditions.
Topical ocular drug delivery to inner ear disease and sinusitis.Mimura, T., Funatsu, H., Usui, T., et al.[2014]
Polymer-eluted dexamethasone (DXM) effectively protects hair cells from TNFalpha-induced loss by altering gene expression, promoting cell survival in an in vitro model using organ of Corti explants.
The study demonstrated that while the polymer alone did not provide protection, the combination of the polymer with DXM significantly reduced hair cell loss, suggesting potential for use in cochlear implants to preserve hearing.
Biopolymer-released dexamethasone prevents tumor necrosis factor alpha-induced loss of auditory hair cells in vitro: implications toward the development of a drug-eluting cochlear implant electrode array.Dinh, C., Hoang, K., Haake, S., et al.[2013]
In a study of 67 patients with idiopathic sensorineural hearing loss, pulse therapy with intravenous methylprednisolone did not show a significant advantage over traditional oral prednisolone in improving hearing outcomes.
Both treatment methods resulted in similar levels of hearing improvement, indicating that pulse therapy may not be more effective than standard oral prednisolone for this condition.
Pulse steroid therapy in idiopathic sudden sensorineural hearing loss: A randomized controlled clinical trial.Eftekharian, A., Amizadeh, M.[2022]

Citations

Association between Statin Use and Sensorineural Hearing ...A survey study reported that statin use was related to a reduced risk of impaired hearing function [21].
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38807496/
Lipids and Statin Medication With Sensorineural Hearing ...This research applied Mendelian randomization (MR) to assess whether lipids and statin medication are associated with an increased risk of SNHL.
3.aao-hnsfjournals.onlinelibrary.wiley.comaao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.1214
Statin Use and Reduced Risk of Sudden Sensorineural ...Evidence from animal models and T2DM patients further supports the protective effects of statins, showing reductions in hearing loss or tinnitus ...
Association between statin medication and hearing ...This study aimed to investigate the association of previous stain use with hearing impairment in an adult population.
Hydrophilic and lipophilic statin use and risk of hearing ...Studies on statins and sensorineural hearing loss have generally found a reduced risk of hearing impairment27,28,29.
Association between statin medication and hearing ...Another prospective study reported a decrease in hearing thresholds at 6 kHz and tinnitus after 6 months of statin use (atorvastatin, ...
Statins and hearingIn preclinical models of cochlear damage and hearing, statins are mainly protective. Clinical studies of statins and hearing are few and inconsistent.
Potential Benefits and Risks Associated with the Use of ...This review aims to provide a comprehensive overview of the mechanism of action, potential advantages, and associated risks of statin utilization in clinical ...
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