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

NCT ID: NCT05455398

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-03-01

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

Conditions

Hearing Loss, Sudden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Round window niche enlargement group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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 injection group

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.

Group Type: ACTIVE_COMPARATOR

Drum chamber drug injection

Intervention Type: PROCEDURE

Injection of drugs into the tympanic chamber through the tympanic membrane

Interventions

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

Intervention Type: PROCEDURE

Drum chamber drug injection

Injection of drugs into the tympanic chamber through the tympanic membrane

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhigang ZHANG, master

Role: STUDY_DIRECTOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu SI, doctor

Role: CONTACT

siyu5@mail.sysu.edu.cn

16620081695

Facility Contacts

Yu Si, doctor

Role: primary

siyu5@mail.sysu.edu.cn

16620081695

Other Identifiers

SYS-Q-202106

Identifier Type: -

Identifier Source: org_study_id