Brief Title
Oral Statins and Protection From Hearing Loss
Official Title
Towards a Self-Administered Hearing Protection Regimen
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 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.
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 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change in Pure Tone Audiometry for Hearing Assessment
Condition
Sudden Sensorineural Hearing Loss
Intervention
Statin
Study Arms / Comparison Groups
Statin
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
June 15, 2022
Completion Date
December 2023
Primary Completion Date
October 2023
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT04826237
Organization ID
STU00212929
Responsible Party
Principal Investigator
Study Sponsor
Northwestern University
Study Sponsor
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Verification Date
April 2022