Comparing oral and intratympanic corticosteroids for sudden hearing loss
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
This study is testing whether taking corticosteroids by mouth or getting them through an injection in the ear works better for people with sudden hearing loss.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Dr. Lutfi Kirdar Kartal Training and Research Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul, Kartal) |
| Trial ID | NCT06968507 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the effectiveness of two corticosteroid treatment methods for patients with sudden sensorineural hearing loss: oral methylprednisolone and intratympanic dexamethasone. Participants will be divided into two groups, with one receiving oral medication and the other receiving intratympanic injections over a specified treatment period. Follow-up visits will occur at regular intervals to assess hearing recovery and overall outcomes. The study seeks to provide clarity on which treatment option yields better results for patients experiencing this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with unilateral sudden sensorineural hearing loss that developed within the last 72 hours.
Not a fit: Patients with a history of hearing-related surgery, chronic ear diseases, or other specified exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify a more effective treatment option for sudden sensorineural hearing loss, potentially improving patient outcomes.
How similar studies have performed: Previous studies have explored corticosteroid treatments for hearing loss, but this specific comparison of oral versus intratympanic administration is less common, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Istanbul, Kartal
- Dr Lütfi Kırdar City Hospital — Istanbul, Kartal, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Koray Islek
- Email: islekkoray@gmail.com
- Phone: +905380457016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.