Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Hearing
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Idiopathic sudden sensorineural hearing loss within 3 months
- •Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid
排除标准
- •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
研究组 & 干预措施
Fludrocortisone
干预措施: Fludrocortisone (Drug)
结局指标
主要结局
Hearing
时间窗: At one month
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.
次要结局
未报告次要终点