acute sensorineural hearing loss
Conditions
Interventions
The registration period for this study is from December 17, 2007 to September 3, 2009. The observation period for the patients is 24 weeks. Biodegradable gelatin hydrogels are made from gelatin in a c
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are patients with acute sensorineural hearing loss, (1) who arediagnosed as definite or probable for the criteria for the diagnosis of idiopathic sudden sensorineural hearing loss (determined by the sudden deafness research committee of the Japanese Ministry of Health, Labour and Welfare in 1973). Subjects satisfy the following conditions; (2) presenting the abnormality in evoked otoacoustic emission, (3) determined as no response by the criteria for hearing improvement after systemic steroid application, (4) diagnosed within 29 days after the onset of hearing loss, (5) age is 20 years or over, (6) possible to come to outpatient clinic of Kyoto University Hospital and (7) give their informed consent to participate in the trial.
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows; (1) presenting active chronic otittis media, acute otittis media, otittis media with effusion or dysfunction of the auditory tube, (2) history of previous other treatments including systemic application of batroxobin, progtagrandin I, and hyper oxygen therapy, except for systemic steroid application, (3) presenting malignant tumors, (4) presenting severe liver dysfunction (AST>100, ALT >100), (5) presenting uncontrolled diabetes (HbA1c>10), (6) presenting pituitary or adrenal dysfunction, (7)severe systemic illness with an expected life expectancy, (8) pregnant or lactating women, (9) history of drug allergy, (10) treated with batroxobin or prostagrandin E1or I after the onset of hearing loss, (11) past history of alcohol or drug dependence within 1 year, (12) individuals who are diagnosed as inappropriate for the trial (ie: difficulty in a 24-week follow up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The therapeutic effects are evaluated 12 weeks after the treatment, using pure tone audiometry. The criteria for hearing improvement, which was determined by the sudden deafness research committee of the Japanese Ministry of Health, Labour and Welfare in 1984, is used in this study. Complete recovery is defined as recovery of a hearing level within 20 dB at all five frequencies tested: 0.25, 0.5, 1.0, 2.0 and 4.0 kHz or recovery to the same level as the opposite side. Marked recovery is defined as more than 30 dB recovery in the mean hearing level at the five frequencies tested. Slight recovery is defined as recovery of 10-29 dB in the mean hearing level at the five frequencies tested. No response is defined as less recovery than 10 dB in the mean hearing level at the five frequencies tested. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcomes are included the ratio of the emergence of adverse events, and the gain of hearing levels of the pure-tone average (0.25, 0.5, 1, 2, 4 kHz) 12 or 24 weeks after the treatment. | — |
Countries
Japan
Contacts
Public ContactTakayuki Nakagawa
Kyoto University Hospital Otolaryngology, Head and Neck Surgery
Outcome results
None listed