Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID06968507

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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

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