Oral Statins and Protection From Hearing Loss

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.

Conditions

Sudden Sensorineural Hearing Loss

Study Overview

Study Details

Study overview

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.

Towards a Self-Administered Hearing Protection Regimen

Oral Statins and Protection From Hearing Loss

Condition
Sudden Sensorineural Hearing Loss
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Donna Whitlon, Ph.D., PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2025-12-31