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| ID | Type | Description | Link |
|---|---|---|---|
| 82225014 | Other Grant/Funding Number | National Science Foundation of China |
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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | OTHER |
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This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.
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: intracochlear dexamethasone injection and intratympanic dexamethasone injection | Experimental | intracochlear injection of dexamethasone through the round window membrane and intratympanic dexamethasone injection through the tympanic membrane |
|
| Group D: intratympanic dexamethasone injection | Active Comparator | intratympanic dexamethasone injection tympanic membrane，once every other day, for a total of 4 injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracochlear triamcinolone acetonide injection | Drug | intracochlear triamcinolone acetonide injection of through the round window membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in pure tone audiometry (PTA) | hearing capacity of thresholds (PTA) | Baseline, Week 2, Week 4, Week12, Week24 |
| Change from Baseline in auditory brainstem response (ABR) | hearing capacity of thresholds (ABR) | Baseline, Week 2, Week 4, Week12, Week24 |
| Change from Baseline in auditory steady state response (ASSR) | hearing capacity of thresholds (ASSR) | Baseline, Week 2, Week 4, Week12, Week24 |
| Change from Baseline in speech Discrimination Scores | hearing capacity of thresholds (speech Discrimination Scores) | Baseline, Week 2, Week 4, Week12, Week24 |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in tinnitus handicap inventory | The THI questionnaire includes functional, emotional, and catastrophic subscales. It consists of 25 questions. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100). | Baseline, Week2, Week4, Week12, Week24 |
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Inclusion Criteria:
Age between 18 and 65 years Unilateral idiopathic sudden sensorineural hearing loss greater than 95dB at the average of 4 frequencies (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) in PTA (contralateral hearing is less than 30dB) at the onset of sudden hearing loss Participant who were treated with standard treatment for 14 days, but no recovery was confirmed as type IV (final hearing level with hearing gain of ≤15 dB) at the end of the 14-day treatment
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"
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenyang Road 83 | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 32296977 |
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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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Parallel Assignment
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single blinded (participant and outcomes assessor)
|
| intracochlear injection of dexamethasone through the round window membrane | Drug | intracochlear injection of dexamethasone sodium phosphate through the round window membrane |
|
|
| intracochlear dexamethasone injection and intratympanic dexamethasone injection | Drug | intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane |
|
|
| intratympanic dexamethasone injection | Drug | intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections. |
|
|
| change from baseline in dizziness handicap inventory | The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes). | Baseline, Week2, Week4, Week12, Week24 |
| change from baseline in quality of life score | Quality of life questionnaire will be measured to compare the change in individual's health-related quality of life using face to face Interview for the scores. Higher scores mean better functioning or fewer symptoms. | Baseline, Week2, Week4, Week12, Week24 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 13457879 | Background | SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available. |
| 30420423 | 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. |
| 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. |
| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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