Could a cholesterol drug help restore sudden hearing loss?
NCT ID NCT04826237
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial asks whether adding an oral statin to the usual steroid treatment can improve recovery from sudden sensorineural hearing loss, a condition where hearing drops rapidly in one ear. Adults diagnosed within 30 days of symptom onset will receive either a statin or a placebo alongside standard steroids. The study measures changes in hearing, speech understanding, and tinnitus to see if the combination works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral statin (atorvastatin) added to standard treatment with methylprednisolone and dexamethasone
- What this could lead to
- If adding a statin improves hearing recovery, it could offer a simple, low-cost addition to standard care for sudden hearing loss.
- What could go wrong
- This is a very small early trial, so results may not apply broadly. Statins can have side effects, and the benefit over standard treatment is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
3 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient older than 18 years and younger than 81 years and * Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical examination, history, audiology, speech interpretation tests and tinnitus evaluation and * Seen in the clinic within the first 30 days after the onset of symptoms. and * Mean hearing threshold equal to or worse than \>30 dB averaged across three consecutive frequencies. * Excellent English Speaking and Comprehension Exclusion Criteria: * Children * Prisoners * Pregnant women * Patients who have experienced similar prior events of SSNHL * Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis, fungal infections, * Autoimmune inner ear disease * Middle ear inflammation or effusion * Ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin, etc. * Head Trauma, lead poisoning * Genetic disorders affecting hearing * Mitochondrial disorders, including MELAS (metabolic encephalopathy, lactic acidosis, and stroke-like episodes), stroke, Cogan's syndrome * Neoplastic (neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous meningitis, intravascular lymphomatosis, others) * Sarcoidosis * Hyperviscosity syndrome * Diabetes * Use of statins within the last 1 month * Allergy, hypersensitivity or intolerance to any components of the study medication * Prior tinnitus * Prior otologic surgery other than ventilation tubes * History of drug abuse or alcoholism within the prior 2 years * Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants, hypnotics or anxiolytics * Severe systemic neurologic disease (epilepsy, Parkinson's, dementia/Alzheimers, multiple sclerosis * Oral steroid treatment within the preceding 2 weeks * Heart disease or TIAs * Chronic kidney failure * HIV, Hepatitis B or C * Active shingles * Skull, facial or temporal bone anomalies COVID-19 immunization within the last 30 days Patients that medically cannot be treated with corticosteroids or statins or that the physician feels have possible coexisting problems that would cause participation in the study to be unsafe
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Sudden sensorineural hearing loss are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.