Phase
Condition
Hearing Impairment
Hearing Loss
Deafness
Treatment
Statin
Placebo
methylprednisolone
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient older than 18 years and younger than 81 years and
Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physicalexamination, history, audiology, speech interpretation tests and tinnitus evaluationand
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 threeconsecutive frequencies.
Excellent English Speaking and Comprehension
Exclusion
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, carcinomatousmeningitis, 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
Study Design
Study Description
Connect with a study center
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
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