Oral Statins for Hearing Loss
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral methylprednisolone and either a statin or placebo for 7 days, with potential intratympanic dexamethasone if no improvement after 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hearing tests and tinnitus evaluation
What Are the Treatments Tested in This Trial?
Interventions
- dexamethasone
- methylprednisolone
- Placebo
- Statin
dexamethasone is already approved in United States, European Union, Canada, Japan for the following indications:
- Allergic reactions
- Blood diseases
- Eye diseases
- Skin diseases
- Respiratory diseases
- Rheumatic diseases
- Gastrointestinal diseases
- Cerebral edema
- Acute asthma
- Chronic obstructive pulmonary disease (COPD)
- Allergic reactions
- Skin diseases
- Eye diseases
- Allergic reactions
- Blood diseases
- Eye diseases
- Skin diseases
- Respiratory diseases
- Rheumatic diseases
- Cerebral edema
- Acute asthma
- Chronic obstructive pulmonary disease (COPD)
- Allergic reactions
- Skin diseases
- Eye diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor