Status:
RECRUITING
Oral Statins and Protection From Hearing Loss
Lead Sponsor:
Northwestern University
Conditions:
Sudden Sensorineural Hearing Loss
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 intr...
Detailed Description
After being informed about the study and potential risks, all patients diagnosed with idopathic sudden sensorineural hearing loss who do not meet the exclusion criteria and do meet the inclusion crite...
Eligibility Criteria
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 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
- 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
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04826237
Start Date
February 9 2023
End Date
December 31 2025
Last Update
December 5 2024
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611