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Taking people in TürkiyePhase 4

Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss

Key facts

Who runs it
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Where
Istanbul, TürkiyeSee the site
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
214 people, planned
Started
25 Dec 2024
Expected to end
10 Sept 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Methylprednisolone (drug)
  • Dexamethasone
Record updated
1 September 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Having a history of previous hearing loss, fluctuating hearing or Meniere's disease, chronic inflammatory or suppurative ear disease or cholesteatoma, otosclerosis
  • 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
  • Having a history of hearing-related surgery other than a ventilation tube
  • Having a history of physical-barotrauma
  • Being under 18 or over 80
  • Presence of structural or retrocochlear pathology in the examination and imaging that would explain the unilateral hearing loss

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in Türkiye

  • Dr Lütfi Kırdar City HospitalIstanbul, TürkiyeContact: Koray IslekTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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)

The 2 groups in the trial

  • oral methylprednisolone treatmentExisting treatment, for comparison

    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).

    Treatment: Methylprednisolone (drug)

  • intratympanic dexamethasone treatmentExisting treatment, for comparison

    Group 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses.

    Treatment: Dexamethasone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT06968507, who can take part
Record updated
1 September 2026