Oral Statins and Protection From Hearing Loss

Northwestern University

Status and phase: Enrolling; Phase 4

Conditions: Sudden Sensorineural Hearing Loss

Treatments: Drug: methylprednisolone; Drug: Statin; Drug: dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04826237

STU00212929

Details and patient eligibility

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.

Full 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 criteria, and who give written informed consent will be enrolled in the trial. A standard treatment for ISSNHL (oral methyprednisolone) will be given to half of the patients and the other half of the patients will receive the standard treatment plus either a placebo or a 7-day course of an HMG-CoA reductase inhibitor (a statin). Patients will return for follow up, the timing and further treatment of which will be determined by the response to the drugs. At each appointment, the patients will see the medical professional, have a hearing test, a speech in noise test, and self evaluate for tinnitus. If there is no improvement after 2 weeks, patient will be offered up to two intratympanic doses of dexamethasone, 10 days apart. This is a randomized, double-blind prospective study. Randomization of males will be separate from that of females.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Statin

Experimental group

Description:

Methylprednisolone+statin (identity and dose to be determined before Trial Begins) Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral statin 1 dose per day for 7 days, beginning with the first dose of methylprednisolone: If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.

Treatment:

Drug: dexamethasone

Drug: Statin

Drug: methylprednisolone

Placebo

Placebo Comparator group

Description:

Methylprednisolone+ placebo. Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral placebo 1 dose per day for 7 days, beginning with the first dose of methylprednisolone If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.

Treatment:

Drug: Placebo

Drug: dexamethasone

Drug: methylprednisolone