High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Compare hearing outcomes between treatment with dexamethasone versus prednisone in
 participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing
 loss).
Sudden sensorineural hearing loss (SSNHL) affects approximately 5 to 20 per 100,000 persons
 with spontaneous recovery seen in 32% to 65%. Many different treatments have been
 investigated in attempt to improve hearing outcomes, with oral corticosteroids having some
 success. Steroid regimens are highly variable, however, retrospective data has suggested
 greater improvement in hearing outcomes with the use of high dose oral steroids
 (dexamethasone) in the setting of unilateral sudden sensorineural hearing loss compared to
 traditional medical therapy with lower dose oral prednisone. The investigators hypothesize
 that patients with unilateral SSNHL who are randomized to treatment with high doses of oral
 dexamethasone will show better hearing outcomes than patients who are randomized to the more
 common standard clinical practice treatment with lower doses of oral prednisone.
Inclusion Criteria:

 -  Adults aged 18 to 80 years old

 -  Present to the Otology or Otolaryngology Clinic at the University of Colorado Hospital
 with unilateral sudden sensorineural hearing loss (SSNHL)

 -  Seen within six weeks of initial hearing loss

 -  Unilateral hearing loss at screening as defined by:

 -  Loss of 30 decibels (dB) HL or greater over 3 continuous frequencies with
 participants reporting that this hearing loss occurred within 3 days

 -  Present with primary complaint of sensorineural hearing loss

 -  Normal tympanometry (Type A)

 -  Normal tympanic membrane

 Exclusion Criteria:

 -  Participants for whom high dose corticosteroids are a contraindicated due to:

 -  Pregnancy

 -  Known allergies to corticosteroids

 -  Other concurrent medical conditions and or medications where high dose oral
 corticosteroids are not safe to use

 -  Participants who have Type 1 or Type 2 diabetes

 -  Participants who have previously received a course of oral steroids for this
 indication

 -  Participants who have bilateral SSNHL

 -  Participants with conductive hearing loss, mixed hearing loss (sensorineural and
 conductive), or any type of hearing loss that is not SSNHL (i.e. caused by acoustic or
 physical trauma to the ear)

 -  Participants with the following conditions/situations will be excluded because the
 possibility that these could cause SSNHL:

 -  History of previous/recurrent unilateral SSNHL

 -  History of fluctuating hearing in either ear

 -  History of Meniere's syndrome

 -  History of chronic granulomatous or suppurative otitis media or cholesteatoma in
 either ear

 -  History of otosclerosis in either ear

 -  Participants with the following conditions/situations will be excluded due to risk of
 misclassification of diagnosis of idiopathic SSNHL or because these participants are
 at higher risk for potential steroid side effects due to other comorbidities. If the
 time line is not otherwise stated, then the participant will be excluded if they
 experienced these criteria at any point in their lifetime:

 -  Received oral steroids (for any indication besides SSNHL) for greater than 21
 days in the preceding 30 days

 -  Systemic fungal infections in the last 6 months

 -  History of tuberculosis or history of prophylactic tuberculosis treatment for
 positive skin test (PPD)

 -  History of unstable angina, coronary artery stenting or bypass graft within 3
 months

 -  History of transient ischemic attacks, cardiac arrhythmia, or stroke in the last
 4 weeks

 -  Serious psychiatric disease or history of psychiatric reaction to
 corticosteroids, specifically bipolar, schizophrenia, episodes of mania or
 delirium

 -  Prior treatment with chemotherapy agents, immunosuppressive drugs, cyclosporine,
 or interferon

 -  Pancreatitis in the last year

 -  Active peptic ulcer disease or history of gastrointestinal bleeding in the last
 year

 -  History of known HIV, hepatitis C, or hepatitis B infection

 -  Chronic renal insufficiency requiring dialysis

 -  Active shingles (herpes zoster infection)

 -  Advanced/severe osteoporosis or nonsurgical aseptic necrosis of the hip