Full-frequency Sudden Hearing Loss
Conditions
Keywords
full-frequency sudden hearing loss, post auricular injection, glucocorticoid, multi-center
Brief summary
The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic injection is the latest findings in clinical work and a new noninvasive way of administration which is gradually expanding research. The aim of this experiment is to verify and explore the efficacy and safety of the postauricular injection treatment with different doses of Glucocorticoids.
Interventions
DRUGDexamethasone Phosphate
5mg; postauricular injection
DRUGGinaton
40mg/pill, 3times/day,oral
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Older than 18 years, less than 60 years old; * patient with unilateral or bilateral（occured successively) acute sensorineural hearing loss(ASNHL) with onset 72hours or less ago. Mean hearing loss compared with the unaffected contralateral ear of at leat 60 dB; * Primary presentation within 2weeks; standard treatment for 2 weeks; * After 2weeks of standard treatment, sensorineural hearing loss (SHL) curative effect evaluation damaged frequencies \>/=30 dB better than before; * Written informed consent before participation in the study.
Exclusion criteria
SYSTEMIC DISEASE * History of tuberculosis or positive purified protein derivative (PPD); * Insulin-dependent diabetes mellitus; * Hypertension, poor control of BP(SBP/DBP)\>=140mmHg); * History of rheumatic disease, e.g. rheumatoid arthritis, scleroderma, lupus, etc; * Serious psychiatric disease or psychiatric reaction to corticosteroids; * History of heart disease or transient ischemic attacks(TIAs); * Prior treatment with chemotherapeutic or immunosuppressive drugs; * Pancreatitis; * Active peptic ulcer disease or history of gastrointestinal bleeding; * History of HIV, Hepatitis B or C; * Chronic kidney failure; * Alcohol abuse; * Active shingles; * Severe osteoporosis or non-surgical aseptic necrosis of the hip; * Without contraindication with glucocorticoid, ginaton, Batroxobin. OTOLOGIC DISEASE * History of Meniere's disease; * History of chronic ear infection; * Prior history of sudden sensorineural hearing loss (SSNHL); * History of fluctuating hearing loss.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pure tone audiometry test | Days 30 | Average change in hearing loss in decibel(dB) between the baseline and D 30 for the three contiguous frequencies with the worst hearing loss, and the treatment efficiency of the 30th day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus with Evaluation questionnaire | days 14,30,90 | Average change in hearing loss in dB between the baseline and D 14, 90 for the three contiguous frequencies with the worst hearing loss; the treatment efficiency of the D 14,90; the treatment efficiency of the tinnitus in D14, 30, 90. |
| Vertigo with Evaluation questionnaire | Day 14,30,90 | Average change in hearing loss in dB between the baseline and D 14, 90 for the three contiguous frequencies with the worst hearing loss; the treatment efficiency of the D 14,90; the treatment efficiency of the vertigo in D14, 30, 90. |
Other
| Measure | Time frame | Description |
|---|---|---|
| the records of adverse reaction and event | Day 2,4,7,14,30,90 | the rate of adverse reaction and event |
Contacts
Primary ContactLisheng Yu, MD
Outcome results
None listed