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| ID | Type | Description | Link |
|---|---|---|---|
| 82225014 | Other Grant/Funding Number | National Science Foundation for Distinguished Young Scholars of China |
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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Shenzhen Second People's Hospital | OTHER |
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Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: intracochlear triamcinolone acetonide injection | Experimental | intracochlear injection of triamcinolone acetonide through the round window membrane |
|
| Group B: intracochlear dexamethasone injection | Experimental | intracochlear injection of dexamethasone through the round window membrane |
|
| Group C: intratympanic dexamethasone injection | Active Comparator | intratympanic dexamethasone injection through tympanic membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Group A: intracochlear triamcinolone acetonide injection | Drug | intracochlear injection of triamcinolone acetonide through the round window membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in auditory brainstem re-sponse (ABR) | hearing capacity of thresholds ( ABR) | Baseline, Week12 |
| Change from Baseline in auditory steady-state response (ASSR) | hearing capacity of thresholds (ASSR) |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Li, MD, Ph.D | Contact | 0086-18301969566 | 619liwei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenyang Road 83 | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31369349 | Background | 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. | |
| 30420423 |
| Label | URL |
|---|---|
| 0 | View source |
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The ethics committee may require approval for data sharing to ensure alignment with principles like beneficence and justice.
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Parallel Assignment
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| intracochlear injection of dexamethasone | Drug | intracochlear injection of dexamethasone through the round window membrane |
|
| intratympanic dexamethasone injection | Device | intratympanic dexamethasone injection through tympanic membrane |
|
| Baseline, Week12 |
| change from baseline in tinnitus handicap inventory | The scales assess changes in vertigo | Baseline, Week2, Week4, Week12, Week24 |
| change from baseline in dizziness handicap inventory | The scales assess changes in vertigo | Baseline, Week2, Week4, Week12, Week24 |
| change from baseline in quality of life score | The scales assess changes in quality of life | Baseline, Week2, Week4, Week12, Week24 |
| Wuqing Wang, MD, Ph.D | Eye & ENT Hospital, Fudan University, Shanghai, China | Principal Investigator |
| 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. |
| 13457879 | Background | SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available. |
| 496191 | Background | McCabe BF. Autoimmune sensorineural hearing loss. Ann Otol Rhinol Laryngol. 1979 Sep-Oct;88(5 Pt 1):585-9. doi: 10.1177/000348947908800501. |
| 7002129 | 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. |
| 8828271 | 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. |
| 29649043 | 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. |
| 21610239 | 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. |
| 18043438 | 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. |
| 36868509 | 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. |
| 18277312 | 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. |
| 32296977 | 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. |
| 38280389 | 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. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |