Sudden hearing loss
Conditions
Interventions
Conventional Intravenous Therapy Group for Sudden Sensorineural Hearing Loss (Control Group):Participants in this group received only the standard conventional intravenous therapy for sudden sensorine
Conventional Intravenous Therapy + Round Window Membrane (RWM) Glucocorticoids Delivery Group (Experimental Group):Participants in this group received the standard intravenous SSNHL treatment regimen
Sponsors
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis: Patients meeting the diagnostic criteria for sudden sensorineural hearing loss (SSNHL) (i.e., sudden-onset, unexplained sensorineural hearing loss with >=30 dB decrease in at least three contiguous frequencies, potentially accompanied by tinnitus, vertigo, ear fullness, etc.), with severe or profound hearing loss (>=65 dB) showing no significant improvement (=10 days of standard SSNHL treatment, or those intolerant to systemic intravenous therapy. 2. Onset-to-visit interval: 10-14 days. 3. Age range: 18-70 years. 4. No contraindications to general anesthesia. 5. Informed consent: Willing to provide written informed consent after understanding the trial protocol and potential risks, with good compliance anticipated.
Exclusion criteria
Exclusion criteria: 1. Concurrent ear diseases: Including chronic suppurative otitis media, middle ear cholesteatoma, external otitis, etc. 2. Sensorineural hearing loss caused by inner ear disorders: Such as Ménière’s disease, acoustic neuroma, inner ear malformations, etc. 3. Systemic diseases: Including severe cardiovascular diseases (e.g., uncontrolled hypertension, coronary artery disease, heart failure), hepatic or renal dysfunction, uncontrolled diabetes, active tuberculosis, peptic ulcer, malignancy, or other systemic conditions where corticosteroid use may exacerbate the disease or interfere with drug metabolism/treatment efficacy. 4. Allergy history: Hypersensitivity to glucocorticoids, absorbable nasal packing materials, anesthetics, or other trial-related drugs/materials, precluding their use. 5. Special populations: Pregnant or lactating women; patients with psychiatric disorders. 6. Genetic hearing loss or family history of hereditary deafness. 7. Systemic diseases or treatments that may affect hearing or surgical procedures. 8. Previous middle/inner ear surgery. 9. Unwilling or unable to comply with the study protocol. 10. Other conditions: Any medical condition deemed by the investigator to preclude safe participation or completion of follow-up assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement Rate of Pure-Tone Audiometry Thresholds; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement degree of pure-tone audiometry (PTA) thresholds;Degree of Speech Discrimination Rate (SDR) Improvement;Evaluation of Auditory Brainstem Response (ABR) Threshold Changes;Evaluation of Auditory Steady-State Response (ASSR) Threshold Changes;Evaluation of Distortion Product Otoacoustic Emission (DPOAE) Amplitude Changes;Tinnitus Symptom Scale Score;Vertigo Symptom Severity Score; | — |
Countries
China
Contacts
Public ContactAo Li
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Outcome results
None listed