Oral Statins for Hearing Loss

Overseen By Donna Whitlon, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Must be taking: Oral steroids

Must not be taking: Ototoxic medications, Statins, Antidepressants, others

Disqualifiers: Diabetes, Heart disease, Psychiatric syndromes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 5 6 7 8}

Who Is on the Research Team?

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

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.

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?

Group I: Statin Experimental Treatment 3 Interventions

Methylprednisolone+statin (identity and dose to be determined before Trial Begins) Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral statin 1 dose per day for 7 days, beginning with the first dose of methylprednisolone: If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.

Group II: Placebo Placebo Group 3 Interventions

Methylprednisolone+ placebo. Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral placebo 1 dose per day for 7 days, beginning with the first dose of methylprednisolone If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.

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

Approved in United States as Decadron for:

• Allergic reactions
• Blood diseases
• Eye diseases
• Skin diseases
• Respiratory diseases
• Rheumatic diseases
• Gastrointestinal diseases

Approved in European Union as Dexamethasone for:

• Cerebral edema
• Acute asthma
• Chronic obstructive pulmonary disease (COPD)
• Allergic reactions
• Skin diseases
• Eye diseases

Approved in Canada as Dexamethasone for:

• Allergic reactions
• Blood diseases
• Eye diseases
• Skin diseases
• Respiratory diseases
• Rheumatic diseases

Approved in Japan as Dexamethasone for:

• Cerebral edema
• Acute asthma
• Chronic obstructive pulmonary disease (COPD)
• Allergic reactions
• Skin diseases
• Eye diseases

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse steroid therapy in idiopathic sudden sensorineural hearing loss: A randomized controlled clinical trial. Eftekharian, A., Amizadeh, M.[2022]

In a 12-month study of 17 patients with refractory autoimmune hearing loss, low-dose methotrexate (MTX) was found to be well tolerated and led to hearing improvement in 65% of participants.

MTX also showed positive effects on vertigo symptoms, with 5 out of 9 patients with Meniere's disease experiencing improvement, suggesting it may be a beneficial treatment for autoimmune-related hearing issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open trial of methotrexate as treatment for autoimmune hearing loss. Matteson, EL., Fabry, DA., Facer, GW., et al.[2022]

In a study of 35 adult patients undergoing cochlear implantation, those receiving intravenous dexamethasone showed a high rate of partial hearing preservation (77.8%), indicating its effectiveness in maintaining residual hearing post-surgery.

The combination of intravenous dexamethasone and oral prednisone also resulted in significant hearing preservation (61.5%), while the control group without steroid treatment had a higher incidence of no measurable hearing (38.5%) after 12 months, highlighting the potential benefits of steroid therapy in cochlear implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Effect of Steroid Therapy on Preserving Residual Hearing after Cochlear Implantation with the Advanced Bionics HiRes Ultra 3D Cochlear Implant System. Skarzynska, MB., Kolodziejak, A., Gos, E., et al.[2022]

In a study of 105 patients with Ménière's disease, intratympanic dexamethasone treatment resulted in hearing stagnation in 68.6% of cases, indicating its effectiveness in preventing further hearing loss.

Additionally, 12.4% of patients experienced actual hearing improvement after treatment, demonstrating a significant correlation between dexamethasone administration and positive auditory outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratympanically administered steroid for progressive sensorineural hearing loss in Ménière's disease. Molnár, A., Maihoub, S., Tamás, L., et al.[2020]

Systemic administration of dexamethasone before cochlear implantation significantly enhances the distribution of the steroid in the inner ear, particularly in areas critical for hearing, such as the organ of Corti and stria vascularis.

The findings support the use of systemic steroids during cochlear implant surgeries to improve hearing preservation, as they show increased uptake in the cochlea despite local administration typically yielding higher drug levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implant surgery facilitates intracochlear distribution of perioperative systemic steroids. Creber, NJ., Eastwood, HT., Hampson, AJ., et al.[2023]

Dexamethasone (Dex) effectively inhibits the activity of the diastrophic dysplasia sulfate transporter (DTDST) in otosclerotic stapes, suggesting a potential mechanism for reducing bone turnover in otosclerosis.

The inhibition of DTDST by Dex is linked to a decrease in interleukin-6 (IL-6) secretion specifically in otosclerotic cells, indicating that glucocorticoids may help manage inflammation and bone remodeling in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucocorticoids inhibit diastrophic dysplasia sulfate transporter activity in otosclerosis by interleukin-6. Imauchi, Y., Lombès, M., Lainé, P., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8625623/

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.gov

pubmed.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.

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aao-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 ...

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nature.com

nature.com/articles/s41598-021-93916-z

Association between statin medication and hearing ...

This study aimed to investigate the association of previous stain use with hearing impairment in an adult population.

5.

nature.com

nature.com/articles/s41598-023-39316-x

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.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8277800/

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, ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0378595522000247

Statins and hearing

In preclinical models of cochlear damage and hearing, statins are mainly protective. Clinical studies of statins and hearing are few and inconsistent.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10892755/

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 ...