Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss

Обзор

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)

Вмешательства

• Препарат Methylprednisolone (drug)
  In our study, we use methylprednisolone as a oral 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)
• Препарат Dexamethasone
  In our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses.

Первичные конечные точки

• odiometric hearing results (PTA) [Срок оценки: from the begining of the treatment in first, second week and first second month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Dr Lütfi Kırdar City Hospital — Istanbul

Идентификаторы

NCT: NCT06968507 · kartalentdepartment

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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