Sudden sensorineural hearing loss
Conditions
Interventions
The gelatin hydrogels immersed with an IGF1 solution are placed into the round window niche in the middle ear.
Intratympanic injections of dexamethasone (four times within seven days)
Sponsors
Graduate School of Medicine, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are patients with sudden sensorineural hearing loss, (1) who are diagnosed 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 recovery or slight recovery by the criteria for hearing improvement after systemic steroid application for more than seven days, (4) diagnosed within 25 days after the onset, (5) age is 20 years or over, (6) possible to come to outpatient clinic 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 otitis media, acute otitis media, otitis media with effusion or dysfunction of the auditory tube, (2) medicated anti-coagulation drugs, (3) presenting following comorbidities; severe liver dysfunction, uncontrolled diabetes, pituitary or adrenal dysfunction, severe systemic illness with an expected life, (4) presenting following past histories; allergy for gelatin, drugs associated with the treatments in this trial, alcohol or drug dependence within 1 year, (5) presenting malignant tumors, (6) pregnant or lactating women, (7) individuals who are diagnosed as inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure was the proportion of patients showing hearing improvement, which was defined as better than slight recovery according to the following criteria 12 weeks after the treatment. 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 recovery is defined as less recovery than 10 dB in the mean hearing level at the five frequencies tested. In this study, hearing improvement is defined as better than slight recovery according to the criteria described above. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures were the proportion of patients showing hearing improvement 16 weeks after the test treatment and the incidence of adverse events during the observation period. | — |
Countries
Japan
Contacts
Public ContactTakayuki Nakagawa
Graduate School of Medicine, Kyoto University Department of Otolaryngology, Head and Neck Surgery
Outcome results
None listed