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Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss

China218 participantsStarted 2021-04-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

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

Timeframe: up to one year

Trial details

NCT IDNCT05455398

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

Contact for this trial

Yu SI, doctor

16620081695 siyu5@mail.sysu.edu.cn

View on ClinicalTrials.gov More Hearing Loss, Sudden trials