Comparison of Efficacy of Intratympanic Methylprednisolone & Intratympanic Dexamethasone in the treatment of Sudden Sensorineural Hearing loss- A Randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To assess the improvement in Pure Tone Audiometry after treatment with intratympanic methylprednisolone versus dexamethasone.
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy of intratympanic methylprednisolone and dexamethasone in the treatment of sudden sensorineural hearing loss SSNHL, an otological emergency with variable prognosis and no clear consensus on optimal steroid therapy. A total of 46 patients aged 18 to 65 years diagnosed with SSNHL greater than or equal to 30 dB hearing loss over at least three consecutive frequencies will be enrolled and randomized into two groups using permuted block randomization.
Group 1 will receive intratympanic methylprednisolone 40 mg perml, and Group 2 will receive intratympanic dexamethasone 4 mg per ml, administered daily for five consecutive days under endoscopic or microscopic guidance. The primary outcome will be improvement in hearing assessed by Pure Tone Audiometry . Secondary outcomes include speech discrimination score, speech reception threshold, patient-reported outcomes, and adverse effects.
Participants will be followed up at 1 week, 2 weeks, and 1 month post-treatment. Hearing recovery will be categorized using Siegel’s criteria. Data will be analyzed using appropriate statistical tests. Ethical approval and informed consent will be obtained prior to study initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient diagnosed with Sudden SNHL,Sudden sensorineural hearing loss is most often defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies presenting within duration of 6 months.
- •Patients aged 18–60 years.
排除标准
- •Patient with conductive or mixed hearing loss Patient with presence of pre-existing otologic conditions such as chronic otitis media, Meniere’s disease, or other inner ear pathologies.
- •Patients with a documented allergy or hypersensitivity to methylprednisolone, dexamethasone, or other corticosteroids.
结局指标
主要结局
To assess the improvement in Pure Tone Audiometry after treatment with intratympanic methylprednisolone versus dexamethasone.
时间窗: To assess the improvement in Pure Tone Audiometry after treatment with intratympanic methylprednisolone versus dexamethasone at baseline, 1 week, 1 month and 6 months
次要结局
未报告次要终点
研究者
Muskan Rao
All India Institute of Medical Sciences, Jammu