Fludrocortisone for Sudden Hearing Loss

Early Phase 1TerminatedNCT01186185

Oregon Health and Science University5 enrolled

Overview

The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 or older * Idiopathic sudden sensorineural hearing loss within 3 months * Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid Exclusion Criteria: * Other diagnosis for the sudden hearing loss * Concurrent systemic use of another steroid * Hypersensitivity to fludrocortisone * Systemic fungal infection * Hypertension requiring two or more medications * Pitting edema * Cardiomegaly * Congestive heart failure * Electrolyte abnormality * Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine

Outcomes

Primary Outcomes

Hearing

Hearing outcome will be determine by pure-tone and speech audiometry measured at the completion of a one-month course of treatment and compared with pre-treatment test results.

Time frame: At one month