ClinicalTrials.gg
Sign In
Not yet recruitingNCT07814677Updated Sep 11, 2026

Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss

A Phase 2 interventional study of intracochlear injection of triamcinolone acetonide through the round window membrane and intratympanic dexamethasone injection through the tympanic membrane in Sudden Hearing Loss, sponsored by Eye & ENT Hospital of Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Eye & ENT Hospital of Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description
  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.
02

Conditions studied

  • Sudden Hearing Loss

Browse trials for

Keywords

  • intracochlear injection
  • glucocorticoid
  • round window membrane
03

In context

Hearing Loss, Sudden

66 studies on the registry are indexed under Hearing Loss, Sudden; 25 are open to participants now.

This study's planned enrollment of 56 is below the median of 72 across 49 interventional studies indexed under Hearing Loss, Sudden.

Browse Hearing Loss, Sudden studies →

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.

Browse Eye & ENT Hospital of Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 The CT diagnosis is "abnormality of the round window niche".

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Group 1：intracochlear dexamethasone injection

    intracochlear injection of triamcinolone acetonide through the round window membrane

    Drug: intracochlear injection of triamcinolone acetonide through the round window membrane

  • Active comparator
    Group 2: intratympanic dexamethasone injection

    intratympanic dexamethasone injection through the tympanic membrane

    Drug: intratympanic dexamethasone injection through the tympanic membrane

Interventions

  • Drugintracochlear injection of triamcinolone acetonide through the round window membrane

    intracochlear injection of triamcinolone acetonide through the round window membrane

  • Drugintratympanic dexamethasone injection through the tympanic membrane

    intratympanic dexamethasone injection through the tympanic membrane

06

What researchers measure

Primary outcomes

  1. Change from Baseline in pure tone audiometry (PTA)

    hearing capacity of thresholds ( PTA)

    Time frame: Baseline , Week2 , Week4, Week12, Week24.

  2. Change from Baseline in Speech Discrimination Scores

    hearing capacity of thresholds ( speech discrimination )

    Time frame: Baseline , Week4, Week12, Week24.

Secondary outcomes

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

    hearing capacity of thresholds ( ABR)

    Time frame: Baseline, Week12

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

    hearing capacity of thresholds (ASSR)

    Time frame: Baseline, Week12

  3. change from baseline in tinnitus handicap inventory

    The scales assess changes in tinnitus

    Time frame: Baseline, Week2, Week4, Week12, Week24

  4. change from baseline in dizziness handicap inventory

    The scales assess changes in vertigo

    Time frame: Baseline, Week2, Week4, Week12, Week24

  5. change from baseline in quality of life score

    The scales assess changes in quality of life

    Time frame: Baseline, Week2, Week4, Week12, Week24

07

Study locations

1 site
  • Eye and ENT Hospital, Fudan University
    Shanghai, Shanghai Municipality 200031, China
    • Wei Li, MD, PhD · Contact619liwei@163.com · 0086-18301969566
    • Wuqing Wang, MD, PhD · Contactwwuqing@eent.shmu.edu.cn · 86-02164377134
    • Yilai Shu, MD, Ph.D · Principal investigator
    • Huawei Li · Principal investigator
    • Wuqing Wang, MD, Ph.D · Principal investigator
08

References and documents

Publications

  • 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. PubMed 38280389 ↗
  • 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. PubMed 32296977 ↗
  • 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. PubMed 18277312 ↗
  • 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. PubMed 36868509 ↗
  • 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. PubMed 18043438 ↗
  • 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. PubMed 21610239 ↗
  • 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. PubMed 29649043 ↗
  • 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. PubMed 8828271 ↗
  • 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. PubMed 7002129 ↗
  • SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available. PubMed 13457879 ↗
  • Fishman JM, Cullen L. Investigating sudden hearing loss in adults. BMJ. 2018 Nov 12;363:k4347. doi: 10.1136/bmj.k4347. No abstract available. PubMed 30420423 ↗
  • 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. PubMed 31369349 ↗

Individual participant data

Plan to share: No — The ethics committee may require approval for data sharing to ensure alignment with principles like beneficence and justice.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Nov 2028, 26 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2026
First posted
Sep 11, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Nov 15, 2028
CompletionEst.
Dec 15, 2028
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07814677
Lead sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Shanghai Zhongshan Hospital, Shenzhen Second People's Hospital
Responsible party
Sponsor
First posted
Sep 11, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Nov 15, 2028 (estimated)
Completion
Dec 15, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Wei Li, MD, Ph.D
Contact
619liwei@163.com
0086-18301969566
Wuqing Wang, MD, Ph.D
Contact
wwuqing@eent.shmu.edu.cn
0086-02164377134 ext. 86-02164377134
Yilai Shu, MD, Ph.D
principal investigator · Eye & ENT Hospital, Fudan University, Shanghai, China
Huawei Li, MD, Ph.D
principal investigator · Eye & ENT Hospital, Fudan University, Shanghai, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hearing Loss, Sudden →

Other studies from this sponsor

Eye & ENT Hospital of Fudan University →

Start the discussion