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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01621256
Eligibility Criteria:
Inclusion Criteria:
* Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
* Symmetric hearing prior to onset of SSHL
* Enrollment has to be accomplished within 7 days after SSHL onset
Exclusion Criteria:
* Bilateral SSHL
* Incomplete recovery after previous SSHL
* Previously existing, known retrocochlear hearing loss
* Any history of any ear operation or local inflammatory disease in the past one year
* History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
* History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
* Treatment with steroids for any reason within the preceding 30 days.
* Body weight \> 140 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01621256
Study Brief:
Protocol Section:
NCT01621256