Actively Recruiting
Comparison of Oral Methylprednisolone and Intratympanic Dexamethasone Treatments for Sudden Sensorineural Hearing Loss
Led by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Updated on 2025-05-13
214
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating which corticosteroid treatment works better for patients with sudden sensorineural hearing loss: oral methylprednisolone or intratympanic dexamethasone. This phase 4 clinical trial focuses on comparing these two treatment methods to determine which is more effective in improving hearing in affected patients. The study includes adults diagnosed with this sudden hearing loss condition and aims to measure improvement through hearing tests over time. Participants are divided into two groups. One group receives oral methylprednisolone daily for two weeks with a tapering dose schedule starting at 48 mg for the first 7 days and decreasing over the following days. The other group receives intratympanic dexamethasone injections every other day for a total of four doses. These treatments are administered under medical supervision, and patients visit the clinic for evaluations during the first and second weeks, and again at one and two months after treatment begins. During the study, participants will undergo hearing tests called audiometric evaluations to monitor changes in hearing ability at multiple time points: the start of treatment, first week, second week, and at one and two months. Additional assessments include temporal MRI scans. Researchers will track treatment adherence and safety throughout the study period. The overall participation extends over at least two months with scheduled clinic visits and evaluations to assess hearing improvement and treatment effects.
CONDITIONS
Brief Title
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age and older
- Sudden sensorineural hearing loss in one ear that developed within 72 hours and has lasted 14 days or less
- Affected ear's pure tone average (PTA) hearing loss over 50 dB at frequencies 500, 1000, 2000, and 4000 Hz
- Hearing in affected ear at least 30 dB lower than healthy ear in three frequencies
- Hearing was symmetrical before onset of hearing loss according to patient's statement
- Steroid use, if any, less than 10 days before enrollment
- Normal cerebellar and vestibular examination results
You will not qualify if you...
- History of ear surgery other than ventilation tube
- Previous hearing loss, fluctuating hearing loss, Meniere's disease, chronic inflammatory or suppurative ear disease, cholesteatoma, or otosclerosis
- Age under 18 or over 80 years
- History of physical barotrauma
- Structural or retrocochlear pathology explaining unilateral hearing loss seen in examination or imaging
- Diagnosed with tuberculosis or receiving tuberculosis prophylactic treatment
- Diabetes mellitus, rheumatological disease, atherosclerotic disease
- Serious psychiatric illness
- Receiving chemotherapy, radiotherapy, or immunosuppressant treatment
- Pancreatitis
- HIV, hepatitis B or C infection
- Chronic renal failure
- Substance abuse
- Active herpetic lesions
- Severe osteoporosis
- Hearing loss within 4 weeks after general anesthesia
- History of head and neck cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive oral methylprednisolone daily for 2 weeks or intratympanic dexamethasone every other day for 4 doses as treatments for sudden sensorineural hearing loss.
Daily visits for oral treatment or 4 visits every other day for intratympanic treatment
Trial Site Locations
Total: 1 location
1
Dr Lütfi Kırdar City Hospital
Istanbul, Kartal, Turkey (Türkiye), 34865
Actively Recruiting
Research Team
K
Koray Islek
V
Volkan Oztemel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here