Actively Recruiting
Towards a Self-Administered Hearing Protection Regimen for Idiopathic Sudden Sensorineural Hearing Loss
Led by Northwestern University · Updated on 2024-12-05
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding an oral statin to the standard treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) can improve hearing outcomes. This small, randomized, double-blind study compares standard care, which includes oral methylprednisolone and possible salvage intratympanic dexamethasone, with the same treatment plus either a statin or a placebo. The goal is to measure changes in hearing ability, speech understanding, and tinnitus experience in patients with ISSNHL. Participants receive oral methylprednisolone in a tapering dose over 11 days starting at 16 mg four times daily. Half of the patients also take an oral statin once daily for seven days beginning with the first steroid dose, while the other half receive a placebo. If there is no hearing improvement after two weeks, up to two doses of intratympanic dexamethasone are offered 10 days apart. Randomization is stratified by gender. During the study, patients attend follow-up visits where hearing tests, speech-in-noise tests, and tinnitus self-evaluations are conducted. Researchers assess changes in pure tone audiometry, speech discrimination, and tinnitus scores from the start to up to four months after initial assessment. The study includes safety monitoring and evaluation of treatment response over this time frame, with total participation lasting up to four months.
CONDITIONS
Brief 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 sudden sensorineural hearing loss
- Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis, fungal infections
- Autoimmune inner ear disease
- Middle ear inflammation or effusion
- Use of ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin
- Head trauma or 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 transient ischemic attacks
- 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
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 11 days of methylprednisolone with 7 days of statin or placebo
Participants receive oral methylprednisolone for 11 days with either a 7-day course of oral statin or placebo. Hearing tests and self-evaluations occur during treatment.
Multiple visits during the 2-week treatment and assessment period
Duration - Up to 4 months after initial assessment
Participants return for follow-up visits for hearing tests, speech tests, and tinnitus evaluation. If no improvement after 2 weeks, up to two intratympanic dexamethasone doses are offered 10 days apart.
Visits scheduled based on response to treatment, including up to 2 intratympanic injections if needed
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
D
Donna Whitlon, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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