Sudden Deafness Treatment Trial
(SSNHL Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
SR
Overseen bySteven Rauch, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Massachusetts Eye and Ear Infirmary
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
SR
Steven Rauch, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary
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
See 4 more
Treatment Details
Interventions
- Methylprednisolone Sodium Succinate (Corticosteroid)
- Prednisone (Corticosteroid)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
Group II: 1Experimental Treatment1 Intervention
Nineteen days of oral prednisone
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New York Eye and Ear InfirmaryNew York, NY
University of Texas Southwestern Medical CenterDallas, TX
Washington University School of MedicineSt. Louis, MO
Baylor College of MedicineHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor
Trials
115
Patients Recruited
15,000+
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Trials
377
Patients Recruited
190,000+