[Multicenter trial for sudden hearing loss therapy - planning and concept].

Area of Science:

• Otolaryngology
• Clinical Trials
• Pharmacology

Background:

• Systemic steroids are the current standard for idiopathic sudden sensorineural hearing loss (ISSHL) primary therapy.
• Current treatment guidelines recommend high-dose steroids without randomized controlled trial (RCT) evidence.
• Treatment rationale is based solely on retrospective cohort studies.

Purpose of the Study:

• To plan and initiate a multicenter, national, randomized, controlled clinical trial (HODOKORT).
• To compare the efficacy of standard-dose versus two high-dose steroid regimens for ISSHL.
• To evaluate the impact on hearing improvement and communication ability.

Main Methods:

• A three-armed, randomized, triple-blind, multicenter trial design.
• Comparison of standard dose with two high-dose glucocorticosteroid treatments.
• Focus on primary systemic therapy for ISSHL patients.

Main Results:

• This section details the planning and initiation phase of the HODOKORT trial.
• The study is designed to gather evidence on high-dose steroid efficacy for ISSHL.
• Specific results on hearing improvement and safety are pending trial completion.

Conclusions:

• The HODOKORT trial aims to provide crucial evidence for ISSHL treatment guidelines.
• Establishing optimal steroid dosage could improve patient hearing and communication outcomes.
• This research addresses a significant gap in the evidence base for ISSHL therapy.