Oral Statins and Protection From Hearing Loss

Trial details

Who runs it

Northwestern University

Trial code

NCT04826237

Record updated

29 October 2026

Original description

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.Read full original descriptionShow less

Towards a Self-Administered Hearing Protection Regimen

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.

Inclusion: 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: Patients who have experienced similar prior events of SSNHL; Ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin, etc; 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; Oral steroid treatment within the preceding 2 weeks; 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; Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis, fungal infections,; Autoimmune inner ear disease; Genetic disorders affecting hearing; Mitochondrial disorders, including MELAS (metabolic encephalopathy, lactic acidosis, and stroke-like episodes), stroke, Cogan's syndrome; Hyperviscosity syndrome; Diabetes; Allergy, hypersensitivity or intolerance to any components of the study medication; Severe systemic neurologic disease (epilepsy, Parkinson's, dementia/Alzheimers, multiple sclerosis; Heart disease or TIAs; Chronic kidney failure; HIV, Hepatitis B or C; Children; Prisoners; Pregnant women; Middle ear inflammation or effusion; Head Trauma, lead poisoning; Neoplastic (neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous meningitis, intravascular lymphomatosis, others); Sarcoidosis; Use of statins within the last 1 month; Active shingles.

ClinicalTrials.gov NCT04826237