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Intracochlear Triamcinolone acetonide in sudden sensorineural hearing loss patients - a prospective observer blinded randomized study
EU CTIS ID: 2024-513145-36-00
What this study is testing
Evaluation of the effect of intracochlear application of triamcinolone acetonide on hearing function measured by the pure tone audiometry, in the treatment of patients with persistent sudden sensorineural hearing loss (SSHL) after unsuccessful conservative therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients between 18 and 80 years within 21 days beginning from the onset of SSHL
- Failed recovery after conservative treatment (systemic and intratympanic steroids) due to persisting SSHL
- Patients with SSHL with a mean hearing threshold shift of ≥30dB in three adjacent frequencies (0.125, 0.25, 0.5, 1, 2, 4, 8 kHz).
- Patients with an absolute mean hearing threshold of ≥70dB in the frequencies 0.5, 1, 2 and 4 kHz.
- Patients who signed the informed consent
You likely can't join if
- Missing informed consent
- Preexisting conductive hearing loss on the affected side (mean air- bone gap >10dB in the frequencies 0.5, 1, 2 and 4 kHz)
- Pregnancy or nursing
- Patients under permanent corticosteroid therapy
- Patients with hearing loss due to a (suspected) rupture of the round window membrane according to their history
- Patients with an intraoperatively detected leak of the round window membrane
See the full eligibility criteria
- Patients between 18 and 80 years within 21 days beginning from the onset of SSHL
- Failed recovery after conservative treatment (systemic and intratympanic steroids) due to persisting SSHL
- Patients with SSHL with a mean hearing threshold shift of ≥30dB in three adjacent frequencies (0.125, 0.25, 0.5, 1, 2, 4, 8 kHz).
- Patients with an absolute mean hearing threshold of ≥70dB in the frequencies 0.5, 1, 2 and 4 kHz.
- Patients who signed the informed consent
- Missing informed consent
- Preexisting conductive hearing loss on the affected side (mean air- bone gap >10dB in the frequencies 0.5, 1, 2 and 4 kHz)
- Pregnancy or nursing
- Patients under permanent corticosteroid therapy
- Patients with hearing loss due to a (suspected) rupture of the round window membrane according to their history
- Patients with an intraoperatively detected leak of the round window membrane
- Repetitive SSHL within the last 12 months on the same side
- Other ear diseases systemic or otologic (e.g. middle ear diseases, vestibular schwannoma, fluctuating hearing loss, Menière ́s Disease)
- Central nervous disorders
- Certain systemic diseases
- Ongoing treatment with aminoglycosides (e.g. gentamicin), erythromycin, tetracycline, chemotherapeutic agents (e.g. cisplatin, 5- fluorouracil, bleomycin), high-dose aspirin (6 to 8 g/day), phosphodiesterase 5 inhibitors (e.g. sildenafil), antimalarial medications (e. g. quinine and chloroquine), loop diuretics (e.g. furosemide, torasemid, acetazolamide), immunosuppressive drugs
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.