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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDr. Lutfi Kirdar Kartal Training and Research Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisolone (drug)

    Drug

    In our study, we use methylprednisolone as a oral 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)

  • Dexamethasone

    Drug

    In our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses.

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: oral methylprednisolone treatmentActive comparator 1 intervention
Group B: intratympanic dexamethasone treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

odiometric hearing results (PTA)

Pure tone audiometry yields hearing threshold values and speech audiometry yields a word recognition score, the highest percentage (0%-100%; normal \>90%) of monosyllabic words identified correctly from digitally recorded standardized 50-word lists presented to each ear of each participant. The primary end point of the study was the change in hearing threshold (dB PTA) from the first audiogram to the 2-month follow-up audiogram. We will define intratympanic or oral treatment to be inferior to other one if the mean post-treatment change in dB PTA of the oral group or intratympanic group exceeds that of the other one by more than 10 dB. Our standard audiometric measure (10 dB) is widely considered the smallest change boundary for clinical reporting of asymetries and air-bone gaps for clinical test procedures (Dirks D. Factors related to bone conduction reliability. Arch Otolaryngol. 1964;79:551-558.)

Time frame
from the begining of the treatment in first, second week and first second month

Secondary outcomes

Other outcomes

Sponsors and contacts

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