Oral Statins and Protection From Hearing Loss

Last updated: December 3, 2024
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

4

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

Statin

Placebo

methylprednisolone

Clinical Study ID

NCT04826237
STU00212929
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient older than 18 years and younger than 81 years and

  • Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physicalexamination, history, audiology, speech interpretation tests and tinnitus evaluationand

  • 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 threeconsecutive frequencies.

  • Excellent English Speaking and Comprehension

Exclusion

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, carcinomatousmeningitis, 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

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Statin
Phase: 4
Study Start date:
February 09, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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