NCT03255473

High Dose Oral Steroids in Sudden Sensorineural Hearing Loss

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sudden Sensorineural Hearing Loss (SSNHL)

Interventions

Type	Name	Description
DRUG	Dexamethasone	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.
DRUG	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.

Timeline

• Start date: 2017-08-30
• Primary completion: 2022-08-01
• Completion: 2023-03-13
• First posted: 2017-08-21
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study