Last updated: July 10, 2022
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hearing Impairment
Deafness
Hearing Loss
Treatment
N/AClinical Study ID
NCT05455398
SYS-Q-202106
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years old, ≤ 65 years old
- The diagnostic criteria for total deafness type of sudden deafness published in 2015were met, and the patient had sudden, unilateral full-frequency severe or very severesensorineural deafness with or without deafness, tinnitus, peri-aural numbness,vertigo, and dizziness, and the diagnosis of sudden deafness was supported by physicalexamination, pure tone audiometry(PTA), acoustic impedance, and auditory brainstemresponse(ABR). Magnetic resonance(MR) of the internal auditory tract ruled out theoccupancy of the internal auditory tract and pontocerebellar region.
- Those with an onset of ≤ 6 weeks who have received a systemic application ofglucocorticoid shock therapy, glucocorticoid intra-drum injections, and medication toimprove inner ear circulation, but have not responded to treatment (PTA improvement < 15 dB).
- No history of middle or inner ear surgery, no history of radiotherapy or chemotherapy;no general anesthesia - contraindication.
- Patients voluntarily participate in this study and sign an informed consent form
Exclusion
Exclusion Criteria:
- Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specificinfections, syndromic deafness malignant tumors.
- Pregnant and lactating women.
- Cannot tolerate general anesthesia surgery, and severe liver and kidney dysfunction.
- Any other conditions that the investigator believes should be excluded from thisstudy.
Study Design
Total Participants: 218
Study Start date:
April 01, 2021
Estimated Completion Date:
March 01, 2024
Connect with a study center
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510030
ChinaActive - Recruiting

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