High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Overview
- Phase
- Phase 2
- Intervention
- Dexamethasone
- Conditions
- Sudden Sensorineural Hearing Loss (SSNHL)
- Sponsor
- University of Colorado, Denver
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Changes in Hearing Threshold (Hearing Improvement)
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss).
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Dexamethasone
All subject identification (ID) numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
Intervention: Dexamethasone
Prednisone
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.
Intervention: Prednisone
Outcomes
Primary Outcomes
Changes in Hearing Threshold (Hearing Improvement)
Time Frame: Baseline, 1 week, 1 month, 3 months
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.
Secondary Outcomes
- Changes in Word Recognition Scores(1 week, 1 month, 3 months, and assessed for change from baseline score.)
- Changes in Pure Tone Averages(1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..)
- Clinical Frequency Analysis Based on Hearing Improvement(Baseline, 1 week, 1 month, 3 months)
- Clinical Percentage Analysis Based on Hearing Improvement(Baseline, 1 week, 1 month, 3 months)