Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
6. september 2026 opdateret af: Eye & ENT Hospital of Fudan University
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
- 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
56
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wei Li, MD, Ph.D
- Telefonnummer: 0086-18301969566
- E-mail: 619liwei@163.com
Undersøgelse Kontakt Backup
- Navn: Wuqing Wang, MD, Ph.D
- Telefonnummer: 86-02164377134 0086-02164377134
- E-mail: wwuqing@eent.shmu.edu.cn
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200031
- Eye and ENT Hospital, Fudan University
-
Kontakt:
- Wei Li, MD, PhD
- Telefonnummer: 0086-18301969566
- E-mail: 619liwei@163.com
-
Ledende efterforsker:
- Wuqing Wang, MD, Ph.D
-
Ledende efterforsker:
- Yilai Shu, MD, Ph.D
-
Kontakt:
- Wuqing Wang, MD, PhD
- Telefonnummer: 86-02164377134
- E-mail: wwuqing@eent.shmu.edu.cn
-
Ledende efterforsker:
- Huawei Li
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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:
- 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".
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group 1：intracochlear dexamethasone injection
intracochlear injection of triamcinolone acetonide through the round window membrane
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intracochlear injection of triamcinolone acetonide through the round window membrane
|
|
Aktiv komparator: Group 2: intratympanic dexamethasone injection
intratympanic dexamethasone injection through the tympanic membrane
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intratympanic dexamethasone injection through the tympanic membrane
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in pure tone audiometry (PTA)
Tidsramme: Baseline , Week2 , Week4, Week12, Week24.
|
hearing capacity of thresholds ( PTA)
|
Baseline , Week2 , Week4, Week12, Week24.
|
|
Change from Baseline in Speech Discrimination Scores
Tidsramme: Baseline , Week4, Week12, Week24.
|
hearing capacity of thresholds ( speech discrimination )
|
Baseline , Week4, Week12, Week24.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring fra baseline i auditiv hjernestamme-respons (ABR)
Tidsramme: Baseline, Uge12
|
høreevne af tærskler (ABR)
|
Baseline, Uge12
|
|
Ændring fra baseline i auditiv steady-state respons (ASSR)
Tidsramme: Udgångspunkt, Uge12
|
høreevne for tærskler (ASSR)
|
Udgångspunkt, Uge12
|
|
ændring fra baseline i dizziness handicap inventory
Tidsramme: Baseline, Uge2, Uge4, Uge12, Uge24
|
Skalaerne vurderer ændringer i svimmelhed
|
Baseline, Uge2, Uge4, Uge12, Uge24
|
|
ændring fra baseline i livskvalitetsscore
Tidsramme: Baseline, Uge2, Uge4, Uge12, Uge24
|
Skalaerne vurderer ændringer i livskvaliteten
|
Baseline, Uge2, Uge4, Uge12, Uge24
|
|
change from baseline in tinnitus handicap inventory
Tidsramme: Baseline, Week2, Week4, Week12, Week24
|
The scales assess changes in tinnitus
|
Baseline, Week2, Week4, Week12, Week24
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Yilai Shu, MD, Ph.D, Eye & ENT Hospital, Fudan University, Shanghai, China
- Ledende efterforsker: Huawei Li, MD, Ph.D, Eye & ENT Hospital, Fudan University, Shanghai, China
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available.
- Fishman JM, Cullen L. Investigating sudden hearing loss in adults. BMJ. 2018 Nov 12;363:k4347. doi: 10.1136/bmj.k4347. No abstract available.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. september 2026
Primær færdiggørelse (Anslået)
15. november 2028
Studieafslutning (Anslået)
15. december 2028
Datoer for studieregistrering
Først indsendt
6. september 2026
Først indsendt, der opfyldte QC-kriterier
6. september 2026
Først opslået (Faktiske)
11. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- intracochlear hearing loss
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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