Oral Statins for Hearing Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
A small clinical trial for idiopathic sudden sensorineural hearing loss (ISSNHL). Will the addition of an oral statin to the standard treatment (oral methylprednesolone and the salvage therapy of intratympanic dexamethasone) improve the treatment outcome for patients with ISSNHL? This study will compare the two treatments and quantitatively evaluate hearing and speech discrimination and have the patients subjectively evaluate tinnitus.
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.
How is the drug used in the Oral Statins for Hearing Loss trial different from other treatments for hearing loss?
The treatment in the trial uses oral steroids like dexamethasone and methylprednisolone, which are typically used for their anti-inflammatory effects, and this approach is unique because it explores the potential of these drugs to protect hearing by reducing inflammation, unlike traditional treatments that may not focus on inflammation control.12345
What data supports the effectiveness of the drug for hearing loss?
Research shows that dexamethasone, when administered directly into the ear, can help prevent the worsening of hearing loss in conditions like Ménière's disease, with some patients even experiencing improvement. This suggests that steroids like dexamethasone may have potential in treating hearing loss.13678
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:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor