Using oral statins to improve hearing loss treatment
Towards a Self-Administered Hearing Protection Regimen
This study is testing if adding a statin to the usual treatment for sudden hearing loss can help improve hearing and reduce ringing in the ears for patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04826237 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether adding an oral statin to the standard treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) can enhance patient outcomes. Participants will be randomly assigned to receive either the standard treatment of oral methylprednisolone or the standard treatment plus a statin or placebo. The study will evaluate changes in hearing, speech discrimination, and subjective tinnitus assessments over time. Follow-up appointments will include hearing tests and evaluations based on patient responses to the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with one-sided idiopathic sudden sensorineural hearing loss within 14 days of symptom onset.
Not a fit: Patients with prior episodes of sudden sensorineural hearing loss or those with certain medical conditions that affect hearing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves hearing recovery for patients with sudden sensorineural hearing loss.
How similar studies have performed: While the use of statins for hearing loss is a novel approach, previous studies have explored various treatments for ISSNHL with mixed results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Donna Whitlon, Ph.D. — Northwestern University
- Study coordinator: Donna Whitlon, Ph.D.
- Email: whitlon@northwestern.edu
- Phone: 8479229047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.