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Effect and Safety of Intratympanic Dexamethasone Combined with Intravenous Dexamethasone versus Other Treatment Regimens in the Treatment of Sudden Sensorineural Hearing Loss: a Multicenter Registration Study

Effect and Safety of Intratympanic Dexamethasone Combined with Intravenous Dexamethasone versus Other Treatment Regimens in the Treatment of Sudden Sensorineural Hearing Loss: a Multicenter Registration Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021245
Enrollment
Unknown
Registered
2019-02-03
Start date
2019-02-11
Completion date
Unknown
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden hearing loss

Interventions

Group A:intratympanic dexamethasone combined with intravenous dexamethasone: Intravenous dexamethasone 0.1mg/ml in 0.9% sodium chloride solution for 100ml per day for 10 days. Within 10 days, dexameth
Group B:Variate regimens: 1. Intratympanic dexamethasone
2. Dexamethasone IV
3. Prednison (oral or IV
4. Batroxobin IV
5. Mannitol IV
6. Mecobalamin IV
7. Prednisolone IT/IV
8. Hyperbaric oxygen therapy
9. Microcirculation improving drugs (e.g. ginaton, etc.), combined use.

Sponsors

Department of Otolaryngology & Head and Neck Surgery, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Unilateral sudden sensorineural hearing loss (SSNHL) onset within 72 hours; 2. Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) in the affected ear = 20 dB worse than contralateral ear in at least two of the four frequencies; 3. Idiopathic hearing loss ; 4. Patients are able to understand Mandarin.

Exclusion criteria

Exclusion criteria: 1. Hearing loss onset longer than 14 days; 2. Bilateral SSNHL; 3. Newly diagnosed patients having received any prior treatment for SSNHL; 4. Otologic disease: 1) Chronic/suppurative otitis media; 2) Cholesteatoma;Meniere's disease; 3) Otosclerosis; 4) Acoustic neuroma; 5) History of ear surgery except ventilation tubes; 6) History of congenital hearing loss; 7) History of genetic/hereditary hearing loss; 8) History of syphilitic hearing loss; 9) History of fluctuating hearing loss; 5. Systemic disease: 1) History of tuberculosis (TB) or positive purified protein derivative of tuberculin (PPD); 2) History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc; 3) Serious psychiatric disease or psychiatric reaction to corticosteroids ; 4) Diseases that require chemotherapy or other immunosuppressive drugs; 5) Pancreatitis; 6) Chronic kidney failure; 7) Severe osteoporosis or non-surgical aseptic necrosis of the hip; 8) Active peptic ulcer disease or history of gastrointestinal bleeding; 9) Contraindications to steroid hormones such as glaucoma; 10) Pregnancy or lactation;

Design outcomes

Primary

MeasureTime frame
PTA;

Secondary

MeasureTime frame
Speech Discrimination Threshold;

Countries

China

Contacts

Public ContactYang Jun

Department of Otolaryngology & Head and Neck Surgery, Xinhua Hospital, Shanghai Jiaotong University School of Medicine

13764981808@126.com+86 13764981808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026