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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

Primary Purpose

Hearing Loss, Sudden

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

Drum chamber drug injection

About this trial

This is an interventional treatment trial for Hearing Loss, Sudden

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Round window niche enlargement group

Drum chamber injection group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05455398

First Posted

June 26, 2022

Last Updated

July 10, 2022

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05455398

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Sudden

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Round window niche enlargement group

Arm Type

Experimental

Arm Description

Arm Title

Drum chamber injection group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Drum chamber drug injection

Intervention Description

Injection of drugs into the tympanic chamber through the tympanic membrane

Primary Outcome Measure Information:

Title

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

Description

Assessment of post-operative hearing improvement by pure tone audiometry

Time Frame

up to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yu SI, doctor

Phone

16620081695

siyu5@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhigang ZHANG, master

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu Si, doctor

Phone

16620081695

siyu5@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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