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New treatment option for Sudden Sensorineural Hearing Loss
Official title Oral Statins and Protection From Hearing Loss
ClinicalTrials.gov ID: NCT04826237
What this study is testing
What is Statin?
Statin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sudden sensorineural hearing loss.
Also referred to as HMG-coA reductase Inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.