Oral Statins and Protection From Hearing Loss

Launched by NORTHWESTERN UNIVERSITY · Mar 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at whether adding an oral statin—medications often used to lower cholesterol—to the standard treatment for sudden hearing loss can help improve outcomes for patients. The standard treatment includes a steroid called methylprednisolone and another treatment delivered directly into the ear. The study will compare these treatments by measuring how well patients can hear and understand speech, as well as how they feel about any ringing in their ears, known as tinnitus.

To be eligible for this trial, participants must be between 18 and 80 years old and have been diagnosed with sudden hearing loss that has no known cause. They need to have seen a doctor within the first two weeks of experiencing symptoms and have a specific level of hearing loss. Unfortunately, some individuals, such as children or those with certain medical conditions, will not be able to participate. If you join the trial, you can expect to receive either the standard treatment or the standard treatment with the statin and will be asked to provide feedback on your hearing and any tinnitus you may experience.

Gender

ALL

Eligibility criteria

• 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 14 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 12 months
• • 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 30 days
• • Heart disease or TIAs
• • Chronic kidney failure
• • HIV, Hepatitis B or C
• • Active shingles
• • Skull, facial or temporal bone anomalies