Clinical trial: Oral Statins and Protection From Hearing Loss (NCT04826237)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Contradiction