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Not yet recruiting NCT07540728

Trans-round Window Membrane Intracochlear Steroid

Phase II Interventional Sudden Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: Group A: intracochlear triamcinolone acetonide injection, intracochlear injection of dexamethasone, intratympanic dexamethasone injection.
Who it may be relevant to
Registry conditions: Sudden Hearing Loss. Basic parameters: 12 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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:

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.

Interventions

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

Primary outcome measures

  • Change from Baseline in pure tone audiometry (PTA) [Time frame: Baseline, Week12,]
  • Change from Baseline in Speech Discrimination Scores [Time frame: Baseline, Week12]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fenyang Road 83 — Shanghai

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. 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

Identifiers

NCT: NCT07540728 · Intracochlear steroid hearing · 82225014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗