Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT05776459
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged between 18 and 85 years
* Unilateral ISSNHL
* Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
* An absolute air conduction hearing threshold of at least 65 dB,
* Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear
Exclusion Criteria:
* Insufficient handling of the language used in the speech audiometry tests
* Bilateral hearing loss
* Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
* Congenital hearing loss
* Conductive hearing loss or combined hearing loss determined by a 4PTA \> 10 dB
* History of ISSNHL in the past 1 years in the affected ear
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05776459
Study Brief:
Protocol Section:
NCT05776459