NCT06968507 Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
| NCT ID | NCT06968507 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dr. Lutfi Kirdar Kartal Training and Research Hospital |
| Condition | Sudden Sensorineural Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2028-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 214 participants in total. It began in 2025-05-20 with a primary completion date of 2028-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 & Investigator
Rasim Yılmazer
STUDY DIRECTOR
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Frequently Asked Questions
Who can join the NCT06968507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sudden Sensorineural Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06968507 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06968507 currently recruiting?
Yes, NCT06968507 is actively recruiting participants. Contact the research team at islekkoray@gmail.com for enrollment information.
Where is the NCT06968507 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06968507 clinical trial?
NCT06968507 is sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. The principal investigator is Rasim Yılmazer at Dr. Lutfi Kirdar Kartal Training and Research Hospital. The trial plans to enroll 214 participants.