Sudden Hearing LossPhase 2NCT07540728
Trans-round Window Membrane Intracochlear Steroid
A Phase 2 study testing Experimental: Group A: intracochlear triamcinolone acetonide injection, intracochlear injection of dexamethasone and intratympanic dexamethasone injection in people with Sudden Hearing Loss, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Sudden Hearing Loss
- What is being tested?
- Experimental: Group A: intracochlear triamcinolone acetonide injection, intracochlear injection of dexamethasone and intratympanic dexamethasone injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fenyang Road 83
Shanghai, Shanghai Municipality, 200031
Wei Li, MD, PhD, 0086-18301969566, 619liwei@163.com
Yilai Shu, MD, Ph.D
About this study
Official title: 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
Read the detailed description
The main questions it aims to answer are:
- Whether is it safe when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
- 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.
- Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating profound or complete sudden sensorineural hearing loss.
- Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.
- Conditions
- Sudden Hearing Loss
- Being tested
- Experimental: Group A: intracochlear triamcinolone acetonide injection, intracochlear injection of dexamethasone, intratympanic dexamethasone injection
- Keywords
- intracochlear injection, glucocorticoid, round window membrane
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Group A: intracochlear triamcinolone acetonide injectionDrug
intracochlear injection of triamcinolone acetonide through the round window membrane
intracochlear injection of dexamethasoneDrug
intracochlear injection of dexamethasone through the round window membrane
intratympanic dexamethasone injectionDevice
intratympanic dexamethasone injection through tympanic membrane
| Study group | Role | What they receive |
|---|---|---|
| Group A: intracochlear triamcinolone acetonide injection | Experimental | intracochlear injection of triamcinolone acetonide through the round window membrane Receives: Drug: Experimental: Group A: intracochlear triamcinolone acetonide injection |
| Group B: intracochlear dexamethasone injection | Experimental | intracochlear injection of dexamethasone through the round window membrane Receives: Drug: intracochlear injection of dexamethasone |
| Group C: intratympanic dexamethasone injection | Active comparator | intratympanic dexamethasone injection through tympanic membrane Receives: Device: intratympanic dexamethasone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in pure tone audiometry (PTA)
hearing capacity of thresholds ( PTA)
Measured: Baseline, Week12,
Change from Baseline in Speech Discrimination Scores
hearing capacity of thresholds ( speech discrimination )
Measured: Baseline, Week12
Secondary outcomes (5)
Change from Baseline in auditory brainstem re-sponse (ABR)
hearing capacity of thresholds ( ABR)
Measured: Baseline, Week12
Change from Baseline in auditory steady-state response (ASSR)
hearing capacity of thresholds (ASSR)
Measured: Baseline, Week12
change from baseline in tinnitus handicap inventory
The scales assess changes in vertigo
Measured: Baseline, Week2, Week4, Week12, Week24
change from baseline in dizziness handicap inventory
The scales assess changes in vertigo
Measured: Baseline, Week2, Week4, Week12, Week24
change from baseline in quality of life score
The scales assess changes in quality of life
Measured: Baseline, Week2, Week4, Week12, Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Apr 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sudden Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shenzhen Second People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yilai Shu, MD, Ph.D, Principal investigator, Eye & ENT Hospital, Fudan University, Shanghai, ChinaHuawei Li, MD, Ph.D, Principal investigator, Eye & ENT Hospital, Fudan University, Shanghai, ChinaWuqing Wang, MD, Ph.D, Principal investigator, Eye & ENT Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540728
- Sponsor's protocol ID
- Intracochlear steroid hearing
- Other IDs
- 82225014
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The ethics committee may require approval for data sharing to ensure alignment with principles like beneficence and justice.
Publications
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 31369349Fishman JM, Cullen L. Investigating sudden hearing loss in adults. BMJ. 2018 Nov 12;363:k4347. doi: 10.1136/bmj.k4347. No abstract available.
PubMed 30420423SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available.
PubMed 13457879McCabe BF. Autoimmune sensorineural hearing loss. Ann Otol Rhinol Laryngol. 1979 Sep-Oct;88(5 Pt 1):585-9. doi: 10.1177/000348947908800501.
PubMed 496191Wilson 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 7002129Silverstein 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 8828271Li 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 29649043Rauch 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 21610239Bird 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 18043438Matsui 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 36868509Plontke 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 18277312Choi 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 32296977Lv 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Trans-Round Window Membrane Intracochlear Steroid Delivery in Patients With Complete Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT07540728
- Acronym / sponsor ID
- Intracochlear steroid hearing
- Conditions
- Sudden Hearing Loss
- Keywords
- intracochlear injection, glucocorticoid, round window membrane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shenzhen Second People's Hospital
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Apr 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
Detailed description
The main questions it aims to answer are:
- Whether is it safe when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
- 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.
- Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating profound or complete sudden sensorineural hearing loss.
- Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group A: intracochlear triamcinolone acetonide injection | Experimental | Drug: Experimental: Group A: intracochlear triamcinolone acetonide injectionintracochlear injection of triamcinolone acetonide through the round window membrane |
| Group B: intracochlear dexamethasone injection | Experimental | Drug: intracochlear injection of dexamethasoneintracochlear injection of dexamethasone through the round window membrane |
| Group C: intratympanic dexamethasone injection | Active comparator | Device: intratympanic dexamethasone injectionintratympanic dexamethasone injection through tympanic membrane |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Group A: intracochlear triamcinolone acetonide injectionintracochlear injection of triamcinolone acetonide through the round window membrane | Drug | Group A: intracochlear triamcinolone acetonide injection |
| intracochlear injection of dexamethasoneintracochlear injection of dexamethasone through the round window membrane | Drug | Group B: intracochlear dexamethasone injection |
| intratympanic dexamethasone injectionintratympanic dexamethasone injection through tympanic membrane | Device | Group C: intratympanic dexamethasone injection |
Primary outcome
Change from Baseline in pure tone audiometry (PTA)
Time frame: Baseline, Week12,
hearing capacity of thresholds ( PTA)
Change from Baseline in Speech Discrimination Scores
Time frame: Baseline, Week12
hearing capacity of thresholds ( speech discrimination )
5 secondary outcomes
Change from Baseline in auditory brainstem re-sponse (ABR)
Time frame: Baseline, Week12
Change from Baseline in auditory steady-state response (ASSR)
Time frame: Baseline, Week12
change from baseline in tinnitus handicap inventory
Time frame: Baseline, Week2, Week4, Week12, Week24
change from baseline in dizziness handicap inventory
Time frame: Baseline, Week2, Week4, Week12, Week24
change from baseline in quality of life score
Time frame: Baseline, Week2, Week4, Week12, Week24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 31369349Chandrasekhar 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.
- Background: PubMed 30420423Fishman JM, Cullen L. Investigating sudden hearing loss in adults. BMJ. 2018 Nov 12;363:k4347. doi: 10.1136/bmj.k4347. No abstract available.
- Background: PubMed 13457879SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available.
- Background: PubMed 496191McCabe BF. Autoimmune sensorineural hearing loss. Ann Otol Rhinol Laryngol. 1979 Sep-Oct;88(5 Pt 1):585-9. doi: 10.1177/000348947908800501.
- Background: PubMed 7002129Wilson 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.
- Background: PubMed 8828271Silverstein 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.
- Background: PubMed 29649043Li 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.
- Background: PubMed 21610239Rauch 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.
- Background: PubMed 18043438Bird 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.
- Background: PubMed 36868509Matsui 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.
- Background: PubMed 18277312Plontke 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.
- Background: PubMed 32296977Choi 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.
- 0Link provided by the sponsor.
- Individual participant dataSharing planned: No. The ethics committee may require approval for data sharing to ensure alignment with principles like beneficence and justice.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
Wuqing Wang, MD, Ph.D principal investigator
Eye & ENT Hospital, Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental: Group A: intracochlear triamcinolone acetonide injection, intracochlear injection of dexamethasone and intratympanic dexamethasone injection in people with Sudden Hearing Loss, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Li, MD, Ph.D (0086-18301969566, 619liwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in pure tone audiometry (PTA) (time frame: Baseline, Week12,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07540728, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.