Health Condition 1: H839- Unspecified disease of inner ear
Conditions
Interventions
Intervention1: Intratympanic Dexamethasone: To ensure accurate injection site selection, audiometric review and patient response will be confirmed the correct ear. The procedure will be taking place w
Sponsors
Dr Kasturi Sarma
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years or above irrespective of gender diagnosed with idiopathic sensorineural hearing loss presented within 2 weeks of onset of hearing loss Sudden unilateral hearing loss of 30 db over at least 4 frequencies (500,1000,2000,4000 HZ) with normal/near normal hearing in contralateral ear. Able to provide informed consent. Willing to comply with study procedures and follow-up visits.
Exclusion criteria
Exclusion criteria: Subjects older than 60 years old (to rule out potential presbycusis); patients with completely hearing loss at 4,000 and 8,000 Hz; patients with Meniere s disease or other recognized pathologies of SSHL, such as genetic causes, acoustic trauma, previous otologic surgery incomplete medical records or inadequate follow-up.Known contraindications to study medications. History of otologic surgery or other significant ear pathology. Concurrent use of medications that may interfere with study outcomes. Barotrauma, noise exposure Otosclerosis, acute otitris media, chronic otitis media, retrocochlear lesion if any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in hearing thresholds measured by pure-tone audiometry. The hearing improvement was defined as more than 15 dB hearing gain, and no improvement as less than 15 dB hearing gainTimepoint: Patient will be review on 1,3 and & 7th day and follow up after 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events if any across the groups, patient-reported outcomes like quality of life improvement, & changes in tinnitus severity. Adverse events if any across the groups along with with causality as per WHO UMC Causality assessment scale, severity assessment as per common terminology criteria for adverse events (CTCAE) V5, patient-reported outcomes (quality of life as per WHO BREF scale, satisfaction with treatment), & changes in tinnitus severity as per Tinnitus Handicap Inventory (THI) ( used to evaluate the degree of discomfort caused by tinnitus) will be evaluated. 2. Cost effectiveness of treatment in both Group A & Group BTimepoint: Pute Tone Audiometry will be done on day zero, day three after 1 week & 1 month of the procedure | — |
Countries
India
Contacts
Public ContactDr Kasturi Sarma
IMS and SUM Hospital
Outcome results
None listed