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Could a cholesterol drug help restore sudden hearing loss?

NCT ID NCT04826237

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.