Trans-round Window Membrane Intracochlear Steroid

April 13, 2026 updated by: Eye & ENT Hospital of Fudan University

Efficacy and Safety of Trans-Round Window Membrane Intracochlear Steroid Delivery in Patients With Complete Sudden Sensorineural Hearing Loss

Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main questions it aims to answer are:

  1. Whether is it safe when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
  2. Whether is it effective in reversing hearing capability when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
  3. Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating profound or complete sudden sensorineural hearing loss.
  4. Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Fenyang Road 83
        • Contact:
        • Principal Investigator:
          • Huawei Li, MD, Ph.D
        • Principal Investigator:
          • Yilai Shu, MD, Ph.D
        • Principal Investigator:
          • Wuqing Li, MD, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 12 and 75 years Unilateral idiopathic sudden sensorineural hearing loss diagnosed by Pure tone test, CT and MRI Symptoms of sudden deafness occur within ≥ 7 days and, after conventional treatment, the average thresholds at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz are ≥ 80 dBHL

Exclusion Criteria:

  • Bilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.

History of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: intracochlear triamcinolone acetonide injection
intracochlear injection of triamcinolone acetonide through the round window membrane
Drug: Experimental: Group A: intracochlear triamcinolone acetonide injection
intracochlear injection of triamcinolone acetonide through the round window membrane
Experimental: Group B: intracochlear dexamethasone injection
intracochlear injection of dexamethasone through the round window membrane
Drug: intracochlear injection of dexamethasone
intracochlear injection of dexamethasone through the round window membrane
Active Comparator: Group C: intratympanic dexamethasone injection
intratympanic dexamethasone injection through tympanic membrane
Device: intratympanic dexamethasone injection
intratympanic dexamethasone injection through tympanic membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in pure tone audiometry (PTA)
Time Frame: Baseline, Week12,
hearing capacity of thresholds ( PTA)
Baseline, Week12,
Change from Baseline in Speech Discrimination Scores
Time Frame: Baseline, Week12
hearing capacity of thresholds ( speech discrimination )
Baseline, Week12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in auditory brainstem re-sponse (ABR)
Time Frame: Baseline, Week12
hearing capacity of thresholds ( ABR)
Baseline, Week12
Change from Baseline in auditory steady-state response (ASSR)
Time Frame: Baseline, Week12
hearing capacity of thresholds (ASSR)
Baseline, Week12
change from baseline in tinnitus handicap inventory
Time Frame: Baseline, Week2, Week4, Week12, Week24
The scales assess changes in vertigo
Baseline, Week2, Week4, Week12, Week24
change from baseline in dizziness handicap inventory
Time Frame: Baseline, Week2, Week4, Week12, Week24
The scales assess changes in vertigo
Baseline, Week2, Week4, Week12, Week24
change from baseline in quality of life score
Time Frame: Baseline, Week2, Week4, Week12, Week24
The scales assess changes in quality of life
Baseline, Week2, Week4, Week12, Week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

Shanghai Zhongshan Hospital
Shenzhen Second People's Hospital

Investigators

  • Principal Investigator: Yilai Shu, MD, Ph.D, Eye & ENT Hospital, Fudan University, Shanghai, China
  • Principal Investigator: Huawei Li, MD, Ph.D, Eye & ENT Hospital, Fudan University, Shanghai, China
  • Principal Investigator: Wuqing Wang, MD, Ph.D, Eye & ENT Hospital, Fudan University, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

April 20, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intracochlear steroid hearing
  • 82225014 (Other Grant/Funding Number: National Science Foundation for Distinguished Young Scholars of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The ethics committee may require approval for data sharing to ensure alignment with principles like beneficence and justice.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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