Sudden Sensorineural Hearing Loss (SSNHL)
Conditions
Keywords
intracochlear injection, glucocorticoid
Brief summary
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.
Detailed description
The main questions it aims to answer are: 1. Whether is it safe when total 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 total 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 total sudden sensorineural hearing loss. 4. Which glucocorticoid intracochlear injection is more effective in patients with total sudden sensorineural hearing loss.
Interventions
DRUGintracochlear triamcinolone acetonide injection
intracochlear triamcinolone acetonide injection of through the round window membrane
DRUGintracochlear injection of dexamethasone through the round window membrane
intracochlear injection of dexamethasone sodium phosphate through the round window membrane
DRUGintracochlear dexamethasone injection and intratympanic dexamethasone injection
intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane
intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections.
Sponsors
Shanghai Zhongshan Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
single blinded (participant and outcomes assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in speech Discrimination Scores | Baseline, Week 2, Week 4, Week12, Week24 | hearing capacity of thresholds (speech Discrimination Scores) |
| Change from Baseline in pure tone audiometry (PTA) | Baseline, Week 2, Week 4, Week12, Week24 | hearing capacity of thresholds (PTA) |
| Change from Baseline in auditory brainstem response (ABR) | Baseline, Week 2, Week 4, Week12, Week24 | hearing capacity of thresholds (ABR) |
| Change from Baseline in auditory steady state response (ASSR) | Baseline, Week 2, Week 4, Week12, Week24 | hearing capacity of thresholds (ASSR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in dizziness handicap inventory | Baseline, Week2, Week4, Week12, Week24 | 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). |
| change from baseline in quality of life score | Baseline, Week2, Week4, Week12, Week24 | 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. |
| change from baseline in tinnitus handicap inventory | Baseline, Week2, Week4, Week12, Week24 | 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). |
Countries
China
Contacts
Primary ContactWei Li, MD, Ph.D
Outcome results
None listed