Sudden sensorineural hearing loss (SSNL) sudden, sensorineural hearing loss
Conditions
Interventions
Topiramate will be prescribed for 12 weeks in total (Start 25 mg at week 1 then 50 mg at week 2 and escalate to a maximum dose of 75 mg at week 3 with 8-week maintenance to week 10 then de-escalate 25
Active Comparator Drug,Placebo Comparator Drug
topiramate,placebo
Sponsors
Faculty of Medicine, Prince of Songkla University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 Patient aged at 18 to 65 years diagnosed with idiopathic SSNHL in Songkhlanagarind hospital (SNHL is defined as a 30 dB or greater sensorineural loss over 3 contiguous frequencies occurring within 3 days ) 2 Patient with BMI > 18.5 (Not underweight according to WHO Asian BMI Classification) 3 Hearing impairment level is at least a mild degree according to WHO classification
Exclusion criteria
Exclusion criteria: Patients with known causes of SSNHL such as labyrinthitis, acoustic tumor etc. Patients with bilateral sudden SSNHL Patient who cannot communicate in Thai language Antecedent fluctuating hearing loss Concurrent severe bilateral vestibular loss with oscillopsia Recent head trauma, barotrauma, or acoustic trauma Previous head and neck radiotherapy Previous ear surgery and middle ear disorder such as chronic otitis media etc. Patient with Sulfa drug allergy and gelatin allergy Patient who was already receiving corticosteroid or migraine preventive medication (Topiramate, Amitriptyline, Propranolol, Flunarizine, Valproate) Patient with G6PD deficiency Patients with leukemia, hemodialysis, or who received previous chemotherapy Pregnancy or trying to become pregnant or Breastfeeding women Patients with major depression disorder or suicide attempt Patients with glaucoma Patients with liver diseases (AST or ALT > 100 IU/L) or renal diseases (GFR < 90 ml/min) Patients with renal stones or history of urinary RBC at 3 or more per HPF Patients whose jobs are related to machines Patients allergic to either topiramate, carbonic anhydrase inhibitor, omeprazole, prednisolone, or methylprednisolone Patients with history of neurocognitive dysfunction or decreased mental function Patients with history of autonomic nervous system dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hearing levels 12th week audiometry in decibel hearing level | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence At the end of the study Excel | — |
Countries
Thailand
Contacts
Public ContactPittayapon Pitathawatchai
Faculty of Medicine, Prince of Songkla University
Outcome results
None listed