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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Changes in Hearing Threshold (Hearing Improvement)
Pure tone averages (from pure tone audiometry) will be recorded for participants at each visit, and assessed for changes in pure tone average over time. Based on a change in pure tone average, participants will be categorized into the different groups.
Time frame: Baseline, 1 week, 1 month, 3 months
Changes in Word Recognition Scores
Word recognition scores from speech audiometry tests will be summarized, by treatment arm, as a continuous variable using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.
Time frame: 1 week, 1 month, 3 months, and assessed for change from baseline score.
Changes in Pure Tone Averages
Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum and will be presented by treatment arm.
Time frame: 1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..
Clinical Frequency Analysis Based on Hearing Improvement
The frequency of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
Time frame: Baseline, 1 week, 1 month, 3 months
Clinical Percentage Analysis Based on Hearing Improvement
The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
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Time frame: Baseline, 1 week, 1 month, 3 months