Clinical trial NCT06968507: Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Official title: Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sudden Sensorineural Hearing Loss
Keywords: intratympanic dexamethasone
Sudden sensorineural hearing loss
oral methylprednisolone
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-13
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: odiometric hearing results (PTA)
timeFrame: from the begining of the treatment in first, second week and first second month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Dr Lütfi Kırdar City Hospital
state: Kartal
Study officials:
affiliation: Dr. Lutfi Kirdar Kartal Training and Research Hospital
name: Rasim Yılmazer
role: STUDY_DIRECTOR
References: