Clinical study of oral prednisone vs intratympanic injection of dexamethasone as initial treatment for sudden hearing loss

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036382

Enrollment

Unknown

Registered

2020-08-22

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-14

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

Conditions

Sudden Hearing Loss

Interventions

Systemic glucocorticoid group:Oral prednisone for 14 days (660mg in total)

Intratympanic injection Dexamethasone 10 mg/ml group:Intratympanic injection Dexamethasone 10 mg/ml (9 times in 14 days)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 80 years old; (2) unilateral deafness occurred within 72 hours, and the average pure tone hearing threshold of 0.5KHz, 1kHz, 2KHz, 4kHz was greater than 60dB; the bilateral hearing was basically symmetrical in the past; (3) the time from the time of treatment to the onset of the disease was not more than 14; (4) the subjects or their legal representatives can understand the purpose of the study, indicating that they have sufficient compliance with the implementation of the study protocol and have normal cognition; they voluntarily participate in the study.

Exclusion criteria

Exclusion criteria: (1) Previous history of deafness in the affected ear or the opposite ear; (2) acute and chronic otitis media, otosclerosis and other middle ear diseases; (3) congenital or hereditary deafness; (4) abnormal development of the inner ear, such as enlargement of vestibular aqueduct and Mondini malformation; (5) history of ear trauma, ear barotrauma or noise induced deafness; (6) inner ear or intracranial tumor; (7) drug-induced deafness; (8) systemic diseases Tuberculosis, insulin-dependent diabetes mellitus, rheumatic disease, active atherosclerotic vascular disease, severe mental or psychological disease, history of chemotherapy or other immunosuppressant treatment, pancreatitis, HIV, hepatitis C or hepatitis B infection, chronic renal insufficiency, active herpes zoster infection, severe osteoporosis, head and neck cancer history or radiation therapy; (9) women in pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Pure tone threshold;	—

Secondary

Measure	Time frame
Speech recognition rate;VEMP;DHI;THI;	—

Countries

China

Contacts

Public ContactWang Jing

Eye and ENT Hospital of Fudan University

jingwang615@126.com+86 18917786267

Outcome results

None listed

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