Oral Statins and Protection From Hearing Loss

Conditions

• Sudden Sensorineural Hearing Loss

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Statin — DRUG
  Oral dose to be taken with methylprednisolone
• methylprednisolone — DRUG
  oral dose, standard of care
• dexamethasone — DRUG
  Drug for intratympanic administration
• Placebo — DRUG
  Capsule the same as for statins but without statin

Study Details

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.

Key Dates

Start date

Feb 9, 2023

Status verified

Dec 2024

Primary completion

Oct 1, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Change in Pure Tone Audiometry for Hearing Assessment [ Time Frame: At the initiation and the end of the study (up to 4 months after initial assessment) ]

Central Contacts

• Donna Whitlon, Ph.D.
  8479229047
  [email protected]

Locations (1)

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