Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
NCT ID: NCT06968507
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
214 participants
INTERVENTIONAL
2025-05-20
2028-09-10
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
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)
intratympanic dexamethasone treatment
Group 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses.
Dexamethasone
In our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses.
Interventions
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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)
Dexamethasone
In our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Dr. Lutfi Kirdar Kartal Training and Research Hospital
OTHER_GOV
Responsible Party
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Koray Islek
Resident Doctor
Principal Investigators
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Rasim Yılmazer
Role: STUDY_DIRECTOR
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Locations
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Dr Lütfi Kırdar City Hospital
Istanbul, Kartal, Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial
FACTORS RELATED TO BONE CONDUCTION RELIABILITY
Other Identifiers
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kartalentdepartment
Identifier Type: -
Identifier Source: org_study_id
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