Towards a Self-Administered Hearing Protection Regimen
Northwestern University
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.
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 wh…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugStatin
Oral dose to be taken with methylprednisolone
- Drugmethylprednisolone
oral dose, standard of care
- Drugdexamethasone
Drug for intratympanic administration
- DrugPlacebo
Capsule the same as for statins but without statin
Location
- Northwestern Memorial HospitalChicago, Illinois