Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country218 target enrollmentApril 1, 2021

ConditionsHearing Loss, Sudden

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hearing Loss, Sudden
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment: 218
Locations: 1
Primary Endpoint: Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

March 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old, ≤ 65 years old
•The diagnostic criteria for total deafness type of sudden deafness published in 2015 were met, and the patient had sudden, unilateral full-frequency severe or very severe sensorineural deafness with or without deafness, tinnitus, peri-aural numbness, vertigo, and dizziness, and the diagnosis of sudden deafness was supported by physical examination, pure tone audiometry(PTA), acoustic impedance, and auditory brainstem response(ABR). Magnetic resonance(MR) of the internal auditory tract ruled out the occupancy of the internal auditory tract and pontocerebellar region.
•Those with an onset of ≤ 6 weeks who have received a systemic application of glucocorticoid shock therapy, glucocorticoid intra-drum injections, and medication to improve 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 Criteria

•Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specific infections, 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 this study.

Outcomes

Primary Outcomes

Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss

Time Frame: up to one year

Assessment of post-operative hearing improvement by pure tone audiometry