Trans-round Window Membrane Intracochlear Steroid
ConditionSudden Hearing Loss
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-75
SponsorEye & ENT Hospital of Fudan University
About this trial
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Experimental: Group A: intracochlear triamcinolone acetonide injection
- intracochlear injection of dexamethasone
- intratympanic dexamethasone injection
Treatment groups
108 Participants
are divided into 3 treatment groupsSponsors and collaborators
Eye & ENT Hospital of Fudan University
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
Source ClinicalTrials.gov