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:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT03974867
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged between 18 to 70 years old;
2. Diagnosed with unilateral ISSNHL according to the National Institute for Deafness and Communication Disorders (NICDC) criteria30: a decrease in hearing of ≥30 decibels (dB), affecting at least 3 consecutive frequencies occurring within a 72-hour period. Since premorbid audiometry is generally unavailable, premorbid hearing level will be defined as the opposite ear's thresholds in this condition;
3. Reported vertigo/dizziness/imbalance/lateropulsion and abnormal results in at least one of the vestibular function tests (including SOT, caloric test, vHIT, cVEMP, and oVEMP);
4. Onset of audio-vestibular symptoms occurred within 7 days;
5. Be willing to sign the informed consent of the study.
Exclusion Criteria:
1. Definite etiologies are found or highly suspected after clinical evaluations, such as vestibular schwannoma, stroke, trauma or demyelinating disease;
2. Diagnosed with a present or previous hearing or balance disorders which might be confused with ISSNHL (history of Meniere's disease, benign paroxysmal positional vertigo, vestibular neuronitis or vestibular migraine; history of otosclerosis; history of luetic, congenital or genetic hearing loss, etc.);
3. Hearing level (evaluated with PTA) in the unaffected ear is abnormal, so that a premorbid hearing level of the affected ear may not be estimated;
4. Suspected as central vestibular dysfunction, evaluated by present and previous medical history, physical examination and VNG;
5. Present with conditions contraindicated systemic glucocorticoids use, such as tuberculosis, hepatitis C or B infection, active herpes zoster infection or other known human immunodeficiency virus, pancreatitis, insulin-dependent diabetes mellitus, severe osteoporosis, chronic renal insufficiency or gastrointestinal ulcer;
6. A history of more than 3 days sufficient systemic glucocorticoids uses (≥1 mg/kg/d) within 3 months which may increase the risk of adverse effects. Considering that the glucocorticoids is a well-acknowledged standard treatment and that the patients might have probably received initial systemic glucocorticoids in emergency before outpatient appointment, we only excluded those who have received sufficient glucocorticoids (≥1mg/kg/d prednisone) for more than 3 days in previous 3 months;
7. Having received other systemic etiological treatments for ISSNHL (including hyperbaric oxcygen therapy (HBOT), thrombolytic drugs and antiviral drugs) which may confound the effects of study drugs. Patients who received only emergency or symptomatic treatments will not be excluded (i.e., betahistine, promethazine, diazepam, mecobalamin or ginkgo biloba leaves extracts);
8. Not appropriate for receiving vestibular function tests due to combination of fracture, inflammatory or suppurative ear disease, severe cervical spondylosis or severe psychotic disorders;
9. Multiple organ dysfunction or unstable vital signs;
10. Pregnancy or lactation;
11. Evaluated as unsuitable for the trial for any other reasons by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03974867
Study Brief:
Protocol Section:
NCT03974867