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

Sun Yat-sen University

Status: Enrolling

Conditions: Hearing Loss, Sudden

Treatments: Procedure: Drum chamber drug injection; Procedure: Surgical treatment of round window niche enlargement via round window for inner ear drug delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT05455398

SYS-Q-202106

Details and patient eligibility

About

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

Enrollment: 218 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old, ≤ 65 years old
2. 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.
3. 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).
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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Round window niche enlargement group

Experimental group

Description:

The round window niche was surgically removed by general anesthesia, the round window membrane was opened as entirely as possible, and the blockage of the round window membrane was carefully identified.

Treatment:

Procedure: Surgical treatment of round window niche enlargement via round window for inner ear drug delivery

Drum chamber injection group

Active Comparator group

Description:

Methylprednisolone (40 mg) was injected via puncture in the posterior quadrant of the tympanic membrane once daily for 7 d. Patients were instructed to remain supine for 30 min to keep the drug in the tympanic chamber and to avoid swallowing to prevent drug flow from the eustachian tube.

Treatment:

Procedure: Drum chamber drug injection