Sudden Deafness Treatment Trial
Condition: Sudden Deafness
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sudden
Intervention: prednisone; methylprednisolone sodium succinate
Intervention description: Oral, 19 days; Four intratympanic injections delivered to the middle ear over 2 weeks
Intervention MeSH terms: Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sudden hearing loss; unilateral sudden sensorineural hearing loss; sudden sensorineural hearing loss; sudden unilateral hearing loss

Summary:

      This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected
      into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing
      loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men/women 18 years and older in good health

          -  Unilateral sensorineural hearing loss developing within 72 hours (SSNHL)

          -  Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with
             the affected ear >/= 30 dB worse than contralateral ear in at least one of the four
             frequencies

          -  Symmetric hearing prior to onset of SSNHL

          -  Hearing loss must be idiopathic

          -  Hearing loss must have occurred within the past 14 days

          -  Must be able to read or write English or Spanish

        Exclusion Criteria:

        SYSTEMIC DISEASE

          -  >21 days prior oral steroid treatment within preceding 30 days

          -  History of tuberculosis (TB) or positive PPD

          -  Insulin-dependent diabetes mellitus

          -  History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc.

          -  Serious psychiatric disease or psychiatric reaction to corticosteroids

          -  History of heart disease or transient ischemic attacks (TIAs)

          -  Prior treatment with chemotherapeutic or immunosuppressive drugs

          -  Pancreatitis

          -  Active peptic ulcer disease or history of gastrointestinal bleeding

          -  History of HIV, Hepatitis B or C

          -  Chronic kidney failure

          -  Alcohol abuse

          -  Active shingles

          -  Severe osteoporosis or non-surgical aseptic necrosis of the hip

        OTOLOGIC DISEASE

          -  Prior history of SSNHL

          -  History of fluctuating hearing loss

          -  History of Meniere's disease

          -  History of chronic ear infection

          -  History of otosclerosis

          -  History of ear surgery (except childhood pressure equalization [pe] tubes)

          -  History of congenital hearing loss

          -  History of trauma immediately preceding onset of SSNHL

          -  History of syphilitic hearing loss

          -  History of genetic/hereditary hearing loss

          -  Skull, facial, or temporal bone anomalies