Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
1 other identifier
interventional
214
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 10, 2028
May 13, 2025
April 1, 2025
3.3 years
April 21, 2025
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
oral methylprednisolone treatment
ACTIVE COMPARATORGroup 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 COMPARATORGroup 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses.
Interventions
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)
In our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Lütfi Kırdar City Hospital
Istanbul, Kartal, 34865, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rasim Yılmazer
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Doctor
Study Record Dates
First Submitted
April 21, 2025
First Posted
May 13, 2025
Study Start
May 20, 2025
Primary Completion (Estimated)
September 10, 2028
Study Completion (Estimated)
September 10, 2028
Last Updated
May 13, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL