Sudden Sensorineural Hearing LossPhase 4NCT06968507
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
A Phase 4 study testing Methylprednisolone (drug) and Dexamethasone in people with Sudden Sensorineural Hearing Loss, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- Methylprednisolone (drug) and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2024to 10 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr Lütfi Kırdar City Hospital
Istanbul, Kartal, 34865
About this study
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:
Read more
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)
- Conditions
- Sudden Sensorineural Hearing Loss
- Being tested
- Methylprednisolone (drug), Dexamethasone
- Keywords
- intratympanic dexamethasone, Sudden sensorineural hearing loss, oral methylprednisolone
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
DexamethasoneDrug
In our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| oral methylprednisolone treatment | Active comparator | 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). Receives: Drug: Methylprednisolone (drug) |
| intratympanic dexamethasone treatment | Active comparator | Group 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: from the begining of the treatment in first, second week and first second month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 Dec 2024
- Primary completion10 Sep 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Koray Islek, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Rasim Yılmazer, Study director, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968507
- Sponsor's protocol ID
- kartalentdepartment
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT06968507
- Acronym / sponsor ID
- kartalentdepartment
- Conditions
- Sudden Sensorineural Hearing Loss
- Keywords
- intratympanic dexamethasone, Sudden sensorineural hearing loss, oral methylprednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 10 Sep 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral methylprednisolone treatment | Active comparator | Drug: Methylprednisolone (drug)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). |
| intratympanic dexamethasone treatment | Active comparator | Drug: DexamethasoneGroup 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone (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) | Drug | oral methylprednisolone treatment |
| DexamethasoneIn our study we use dexamethasone 8mg/2ml form as intratympanic treatment every other day, totally 4 doses. | Drug | intratympanic dexamethasone treatment |
Primary outcome
odiometric hearing results (PTA)
Time frame: from the begining of the treatment in first, second week and first second month
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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trialLink provided by the sponsor.
- FACTORS RELATED TO BONE CONDUCTION RELIABILITYLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rasim Yılmazer study director
Dr. Lutfi Kirdar Kartal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone (drug) and Dexamethasone in people with Sudden Sensorineural Hearing Loss, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koray Islek (+905380457016, islekkoray@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
odiometric hearing results (PTA) (time frame: from the begining of the treatment in first, second week and first second month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.