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: 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/A

Clinical Study ID

NCT05455398
SYS-Q-202106
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old, ≤ 65 years old
  2. 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.
  3. 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).
  4. No history of middle or inner ear surgery, no history of radiotherapy or chemotherapy;no general anesthesia - contraindication.
  5. Patients voluntarily participate in this study and sign an informed consent form

Exclusion

Exclusion Criteria:

  1. Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specificinfections, syndromic deafness malignant tumors.
  2. Pregnant and lactating women.
  3. Cannot tolerate general anesthesia surgery, and severe liver and kidney dysfunction.
  4. 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
    China

    Active - Recruiting

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