Trans-round Window Membrane Intracochlear Steroid

Официальное название

Efficacy and Safety of Trans-Round Window Membrane Intracochlear Steroid Delivery in Patients With Complete Sudden Sensorineural Hearing Loss

Обзор

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

Подробное описание

The main questions it aims to answer are:

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.

Вмешательства

• Препарат Experimental: Group A: intracochlear triamcinolone acetonide injection
  intracochlear injection of triamcinolone acetonide through the round window membrane
• Препарат intracochlear injection of dexamethasone
  intracochlear injection of dexamethasone through the round window membrane
• Устройство intratympanic dexamethasone injection
  intratympanic dexamethasone injection through tympanic membrane

Первичные конечные точки

• Change from Baseline in pure tone audiometry (PTA) [Срок оценки: Baseline, Week12,]
• Change from Baseline in Speech Discrimination Scores [Срок оценки: Baseline, Week12]

Вторичные конечные точки (5)

• Change from Baseline in auditory brainstem re-sponse (ABR) [Срок оценки: Baseline, Week12]
• Change from Baseline in auditory steady-state response (ASSR) [Срок оценки: Baseline, Week12]
• change from baseline in tinnitus handicap inventory [Срок оценки: Baseline, Week2, Week4, Week12, Week24]
• change from baseline in dizziness handicap inventory [Срок оценки: Baseline, Week2, Week4, Week12, Week24]
• change from baseline in quality of life score [Срок оценки: Baseline, Week2, Week4, Week12, Week24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fenyang Road 83 — Шанхай

Публикации

• 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. PMID 31369349
• Fishman JM, Cullen L. Investigating sudden hearing loss in adults. BMJ. 2018 Nov 12;363:k4347. doi: 10.1136/bmj.k4347. No abstract available. PMID 30420423
• SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available. PMID 13457879
• McCabe BF. Autoimmune sensorineural hearing loss. Ann Otol Rhinol Laryngol. 1979 Sep-Oct;88(5 Pt 1):585-9. doi: 10.1177/000348947908800501. PMID 496191
• 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. PMID 7002129
• 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. PMID 8828271
• 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. PMID 29649043
• 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. PMID 21610239

Идентификаторы

NCT: NCT07540728 · Intracochlear steroid hearing · 82225014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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