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

Hearing Loss, Sudden Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455398
• Other study ID #: SYS-Q-202106
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: July 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yu SI, doctor
• Phone: 16620081695
• Email: siyu5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: March 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sudden

Intervention

Procedure:
• Surgical treatment of round window niche enlargement via round window for inner ear drug delivery
The round window niche is surgically removed and the hormone is slowly released into the inner ear using a gelatin sponge that has absorbed the hormone in the round window
• Drum chamber drug injection
Injection of drugs into the tympanic chamber through the tympanic membrane

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss	Assessment of post-operative hearing improvement by pure tone audiometry	up to one year