Trans-round Window Membrane Intracochlear Steroid

NCT07540728 | Not Yet Recruiting Phase 2

• 2 other identifiers: Intracochlear steroid hearing82225014
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sudden Hearing Loss

Keywords

intracochlear injection; glucocorticoid; round window membrane

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in pure tone audiometry (PTA)

  hearing capacity of thresholds ( PTA)

  Baseline, Week12,

• Change from Baseline in Speech Discrimination Scores

  hearing capacity of thresholds ( speech discrimination )

  Baseline, Week12

Secondary Outcomes (5)

• Change from Baseline in auditory brainstem re-sponse (ABR)

  Baseline, Week12

• Change from Baseline in auditory steady-state response (ASSR)

  Baseline, Week12

• change from baseline in tinnitus handicap inventory

  Baseline, Week2, Week4, Week12, Week24

• change from baseline in dizziness handicap inventory

  Baseline, Week2, Week4, Week12, Week24

• change from baseline in quality of life score

  Baseline, Week2, Week4, Week12, Week24

Study Arms (3)

Group A: intracochlear triamcinolone acetonide injection

EXPERIMENTAL

intracochlear injection of triamcinolone acetonide through the round window membrane

Drug: Experimental: Group A: intracochlear triamcinolone acetonide injection

Group B: intracochlear dexamethasone injection

EXPERIMENTAL

intracochlear injection of dexamethasone through the round window membrane

Drug: intracochlear injection of dexamethasone

Group C: intratympanic dexamethasone injection

ACTIVE COMPARATOR

intratympanic dexamethasone injection through tympanic membrane

Device: intratympanic dexamethasone injection

Interventions

Experimental: Group A: intracochlear triamcinolone acetonide injection DRUG

intracochlear injection of triamcinolone acetonide through the round window membrane

Group A: intracochlear triamcinolone acetonide injection

intracochlear injection of dexamethasone DRUG

intracochlear injection of dexamethasone through the round window membrane

Group B: intracochlear dexamethasone injection

intratympanic dexamethasone injection DEVICE

intratympanic dexamethasone injection through tympanic membrane

Group C: intratympanic dexamethasone injection

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Shanghai Zhongshan Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Fenyang Road 83

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (13)

• Chandrasekhar SS, Tsai Do BS, Schwartz SR, Bontempo LJ, Faucett EA, Finestone SA, Hollingsworth DB, Kelley DM, Kmucha ST, Moonis G, Poling GL, Roberts JK, Stachler RJ, Zeitler DM, Corrigan MD, Nnacheta LC, Satterfield L, Monjur TM. Clinical Practice Guideline: Sudden Hearing Loss (Update) Executive Summary. Otolaryngol Head Neck Surg. 2019 Aug;161(2):195-210. doi: 10.1177/0194599819859883.

  PMID: 31369349 BACKGROUND

• Fishman JM, Cullen L. Investigating sudden hearing loss in adults. BMJ. 2018 Nov 12;363:k4347. doi: 10.1136/bmj.k4347. No abstract available.

  PMID: 30420423 BACKGROUND

• SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available.

  PMID: 13457879 BACKGROUND

• McCabe BF. Autoimmune sensorineural hearing loss. Ann Otol Rhinol Laryngol. 1979 Sep-Oct;88(5 Pt 1):585-9. doi: 10.1177/000348947908800501.

  PMID: 496191 BACKGROUND

• Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Arch Otolaryngol. 1980 Dec;106(12):772-6. doi: 10.1001/archotol.1980.00790360050013.

  PMID: 7002129 BACKGROUND

• Silverstein H, Choo D, Rosenberg SI, Kuhn J, Seidman M, Stein I. Intratympanic steroid treatment of inner ear disease and tinnitus (preliminary report). Ear Nose Throat J. 1996 Aug;75(8):468-71, 474, 476 passim.

  PMID: 8828271 BACKGROUND

• Li W, Hartsock JJ, Dai C, Salt AN. Permeation Enhancers for Intratympanically-applied Drugs Studied Using Fluorescent Dexamethasone as a Marker. Otol Neurotol. 2018 Jun;39(5):639-647. doi: 10.1097/MAO.0000000000001786.

  PMID: 29649043 BACKGROUND

• Rauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011 May 25;305(20):2071-9. doi: 10.1001/jama.2011.679.

  PMID: 21610239 BACKGROUND

• Bird PA, Begg EJ, Zhang M, Keast AT, Murray DP, Balkany TJ. Intratympanic versus intravenous delivery of methylprednisolone to cochlear perilymph. Otol Neurotol. 2007 Dec;28(8):1124-30. doi: 10.1097/MAO.0b013e31815aee21.

  PMID: 18043438 BACKGROUND

• Matsui H, Lopez IA, Ishiyama G, Ishiyama A. Immunohistochemical localization of glucocorticoid receptors in the human cochlea. Brain Res. 2023 May 1;1806:148301. doi: 10.1016/j.brainres.2023.148301. Epub 2023 Mar 1.

  PMID: 36868509 BACKGROUND

• Plontke SK, Biegner T, Kammerer B, Delabar U, Salt AN. Dexamethasone concentration gradients along scala tympani after application to the round window membrane. Otol Neurotol. 2008 Apr;29(3):401-6. doi: 10.1097/MAO.0b013e318161aaae.

  PMID: 18277312 BACKGROUND

• Choi JW, Lee CK, Kim SB, Lee DY, Ko SC, Park KH, Choi SJ. Potential benefits of salvage intratympanic dexamethasone injection in profound idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2219-2227. doi: 10.1007/s00405-020-05967-z. Epub 2020 Apr 15.

  PMID: 32296977 BACKGROUND

• Lv J, Wang H, Cheng X, Chen Y, Wang D, Zhang L, Cao Q, Tang H, Hu S, Gao K, Xun M, Wang J, Wang Z, Zhu B, Cui C, Gao Z, Guo L, Yu S, Jiang L, Yin Y, Zhang J, Chen B, Wang W, Chai R, Chen ZY, Li H, Shu Y. AAV1-hOTOF gene therapy for autosomal recessive deafness 9: a single-arm trial. Lancet. 2024 May 25;403(10441):2317-2325. doi: 10.1016/S0140-6736(23)02874-X. Epub 2024 Jan 24. Erratum In: Lancet. 2024 May 25;403(10441):2292. doi: 10.1016/S0140-6736(24)01040-7.

  PMID: 38280389 BACKGROUND

Related Links

• 0

MeSH Terms

Conditions

Hearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Li, MD, Ph.D

CONTACT

0086-18301969566; 619liwei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 20, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)