Towards a Self-Administered Hearing Protection Regimen

Who is this study for? Patients with Sudden Sensorineural Hearing Loss
What treatments are being studied? Methylprednisolone+Dexamethasone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

A small clinical trial for idiopathic sudden sensorineural hearing loss (ISSNHL). Will the addition of an oral statin to the standard treatment (oral methylprednesolone and the salvage therapy of intratympanic dexamethasone) improve the treatment outcome for patients with ISSNHL? This study will compare the two treatments and quantitatively evaluate hearing and speech discrimination and have the patients subjectively evaluate tinnitus.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patient older than 18 years and younger than 81 years and

• Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical examination, history, audiology, speech interpretation tests and tinnitus evaluation and

• Seen in the clinic within the first 14 days after the onset of symptoms. and

• Mean hearing threshold equal to or worse than \>30 dB averaged across three consecutive frequencies.

• Excellent English Speaking and Comprehension

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Contact Information
Primary
Donna Whitlon, Ph.D.
whitlon@northwestern.edu
8479229047
Time Frame
Start Date: 2023-02-09
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Statin
Methylprednisolone+statin (identity and dose to be determined before Trial Begins) Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day;~Oral statin 1 dose per day for 7 days, beginning with the first dose of methylprednisolone:~If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.
Placebo_comparator: Placebo
Methylprednisolone+ placebo. Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral placebo 1 dose per day for 7 days, beginning with the first dose of methylprednisolone~If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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