Actively Recruiting
Oral Statins and Protection From Hearing Loss
Led by Northwestern University · Updated on 2024-12-05
100
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Oral Statins and Protection From Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 18 years and younger than 81 years
- Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical examination, history, audiology, speech interpretation tests and tinnitus evaluation
- Seen in the clinic within the first 14 days after the onset of symptoms
- Mean hearing threshold equal to or worse than >30 dB averaged across three consecutive frequencies
- Excellent English speaking and comprehension
You will not qualify if you...
- 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, stroke, Cogan's syndrome
- Neoplastic conditions such as neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous meningitis, intravascular lymphomatosis
- 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 including 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
D
Donna Whitlon, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here