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RecruitingNCT06968507Updated Sep 1, 2026

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

A Phase 4 interventional study of Methylprednisolone (drug) and Dexamethasone in Sudden Sensorineural Hearing Loss, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2024, registered Apr 2025).
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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)
02

Conditions studied

  • Sudden Sensorineural Hearing Loss

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Keywords

  • intratympanic dexamethasone
  • Sudden sensorineural hearing loss
  • oral methylprednisolone
03

In context

Hearing Loss, Sudden

66 studies on the registry are indexed under Hearing Loss, Sudden; 25 are open to participants now.

This study's planned enrollment of 214 is above the median of 72 across 49 interventional studies indexed under Hearing Loss, Sudden.

Browse Hearing Loss, Sudden studies →

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 78 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, use should be less than 10 days
  • Cerebellar and vestibular examination should be normal

Exclusion criteria

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 treatment, pancreatitis patients, , 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
214 participants (estimated)

Study arms

  • Active comparator
    oral methylprednisolone treatment

    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).

    Drug: Methylprednisolone (drug)

  • Active comparator
    intratympanic dexamethasone treatment

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

    Drug: Dexamethasone

Interventions

  • 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)

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06968507
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
Koray Islek (Resident Doctor, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
May 13, 2025
Start date
Dec 25, 2024
Primary completion
Sep 10, 2028 (estimated)
Completion
Sep 10, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Koray Islek
Contact
islekkoray@gmail.com
+905380457016
Volkan Oztemel
Contact
Volkanoztemel508@gmail.com
+095396726250
Rasim Yılmazer
study director · Dr. Lutfi Kirdar Kartal Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Methylprednisolone · Dexamethasone

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