Oral Statins and Protection From Hearing Loss

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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

May 15, 2021

Completion Date

September 2023

Primary Completion Date

July 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

, , 



Administrative Informations


NCT ID

NCT04826237

Organization ID

STU00212929


Responsible Party

Principal Investigator

Study Sponsor

Northwestern University


Study Sponsor

, , 


Verification Date

March 2021