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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral methylprednisolone treatment | Active Comparator | 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). |
|
| intratympanic dexamethasone treatment | Active Comparator | Group 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone (drug) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| odiometric hearing results (PTA) | 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.) | from the begining of the treatment in first, second week and first second month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koray Islek | Contact | +905380457016 | islekkoray@gmail.com | |
| Volkan Oztemel | Contact | +095396726250 | Volkanoztemel508@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rasim Yılmazer | Dr. Lutfi Kirdar Kartal Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Lütfi Kırdar City Hospital | Recruiting | Istanbul | Kartal | 34865 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial | View source |
| FACTORS RELATED TO BONE CONDUCTION RELIABILITY | View source |
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| Dexamethasone | Drug | In our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses. |
|
| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D004364 | Pharmaceutical Preparations |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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