Sudden Hearing Loss
Conditions
Keywords
intracochlear injection, glucocorticoid, round window membrane
Brief summary
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
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
DRUGintracochlear injection of triamcinolone acetonide through the round window membrane
intracochlear injection of triamcinolone acetonide through the round window membrane
DRUGintratympanic dexamethasone injection through the tympanic membrane
intratympanic dexamethasone injection through the tympanic membrane
Sponsors
Eye & ENT Hospital of Fudan University
Shanghai Zhongshan Hospital
Shenzhen Second People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
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".
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in pure tone audiometry (PTA) | Baseline , Week2 , Week4, Week12, Week24. | hearing capacity of thresholds ( PTA) |
| Change from Baseline in Speech Discrimination Scores | Baseline , Week4, Week12, Week24. | hearing capacity of thresholds ( speech discrimination ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in auditory brainstem re-sponse (ABR) | Baseline, Week12 | hearing capacity of thresholds ( ABR) |
| Change from Baseline in auditory steady-state response (ASSR) | Baseline, Week12 | hearing capacity of thresholds (ASSR) |
| change from baseline in tinnitus handicap inventory | Baseline, Week2, Week4, Week12, Week24 | The scales assess changes in tinnitus |
| change from baseline in dizziness handicap inventory | Baseline, Week2, Week4, Week12, Week24 | The scales assess changes in vertigo |
| change from baseline in quality of life score | Baseline, Week2, Week4, Week12, Week24 | The scales assess changes in quality of life |
Countries
China
Contacts
CONTACTWei Li, MD, Ph.D
CONTACTWuqing Wang, MD, Ph.D
PRINCIPAL_INVESTIGATORYilai Shu, MD, Ph.D
Eye & ENT Hospital, Fudan University, Shanghai, China
PRINCIPAL_INVESTIGATORHuawei Li, MD, Ph.D
Eye & ENT Hospital, Fudan University, Shanghai, China
Outcome results
None listed