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RecruitingPhase 4NCT04826237

Oral Statins and Protection From Hearing Loss

Towards a Self-Administered Hearing Protection Regimen

Sponsor

Northwestern University

Enrollment

100 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria28

  • 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

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Interventions

DRUGStatin

Oral dose to be taken with methylprednisolone

DRUGmethylprednisolone

oral dose, standard of care

DRUGdexamethasone

Drug for intratympanic administration

DRUGPlacebo

Capsule the same as for statins but without statin

Locations(1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

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NCT04826237