Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- odiometric hearing results (PTA)
研究概览
简要总结
The goal of this clinical trial is to learn which one works to treat better in patients with sudden sensorineural hearing loss, oral or intratympanic corticosteroid treatment.
The main question it aims to answer is:
Which corticosteroid treatment is more effective in patients with sudden sensorineural hearing loss, oral or intratympanic?
- In our study, it was planned to divide the treatment schemes compared into two groups. Group 1 included patients who received oral methylprednisolone treatment daily for 2 weeks (48 mg for the first 7 days, 32 mg for the following 2 days, 16 mg for the 2 days, and 8 mg for the last 3 days). Group 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses.
- Visit the clinic after diagnose in first week, second week, first month and second month for checkups and tests ( temporal MR, odimetric results)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Unilateral sudden sensorineural hearing loss that developed within 72 hours and has lasted for 14 days or less
- •Affected side PTA (500-100-2000-4000hz) should be over 50dB
- •Affected side should be at least 30dB lower than healthy side in 3 frequencies
- •Hearing should be symmetrical according to patient's statement before sensorineural hearing loss
- •If used, steroid use should be less than 10 days
- •Cerebellar and vestibular examination should be normal
排除标准
- •Having a history of hearing-related surgery other than a ventilation tube
- •Having a history of previous hearing loss, fluctuating hearing or Meniere's disease, chronic inflammatory or suppurative ear disease or cholesteatoma, otosclerosis
- •Being under 18 or over 80
- •Having a history of physical-barotrauma
- •Presence of structural or retrocochlear pathology in the examination and imaging that would explain the unilateral hearing loss
- •Patients diagnosed with tuberculosis or receiving prophylactic tuberculosis treatment, diabetes mellitus, rheumatological patients, those with atherosclerotic disease, serious psychiatric patients, those receiving chemotherapy, radiotherapy or immunosuppressant treatment, pancreatitis patients, HIV, hepatitis C and B patients, those with chronic renal failure, substance abusers, those with active herpetic lesions, severe osteoporosis patients, those with hearing loss within 4 weeks after general anesthesia, those with a history of head and neck cancer.
研究组 & 干预措施
oral methylprednisolone treatment
Group 1 included patients who received oral methylprednisolone treatment daily for 2 weeks (48 mg for the first 7 days, 32 mg for the following 2 days, 16 mg for the 2 days, and 8 mg for the last 3 days).
干预措施: Methylprednisolone (drug) (Drug)
intratympanic dexamethasone treatment
Group 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
odiometric hearing results (PTA)
时间窗: from the begining of the treatment in first, second week and first second month
Pure tone audiometry yields hearing threshold values and speech audiometry yields a word recognition score, the highest percentage (0%-100%; normal \>90%) of monosyllabic words identified correctly from digitally recorded standardized 50-word lists presented to each ear of each participant. The primary end point of the study was the change in hearing threshold (dB PTA) from the first audiogram to the 2-month follow-up audiogram. We will define intratympanic or oral treatment to be inferior to other one if the mean post-treatment change in dB PTA of the oral group or intratympanic group exceeds that of the other one by more than 10 dB. Our standard audiometric measure (10 dB) is widely considered the smallest change boundary for clinical reporting of asymetries and air-bone gaps for clinical test procedures (Dirks D. Factors related to bone conduction reliability. Arch Otolaryngol. 1964;79:551-558.)
次要结局
未报告次要终点
研究者
Koray Islek
Resident Doctor
Dr. Lutfi Kirdar Kartal Training and Research Hospital