A randomized controlled trial of round window niche dilling with inner ear administration via round window as a salvage therapy for sudden hearing loss

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052942

Enrollment

Unknown

Registered

2021-11-06

Start date

2021-11-07

Completion date

Unknown

Last updated

2022-08-30

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

Conditions

Hearing loss

Interventions

Experiment group:The round window niche was enlarged, and methylprednisolone 40mg was administered through the inner ear of the round window, once a day for 10 days in total

Control group:Intratympanic injection of methylprednisolone 40mg once a day for 10 days

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Sudden hearing loss patients with total deafness were treated with systemic glucocorticoid pulse therapy and intratympanic injection of glucocorticoids within 2-6 weeks after the onset of the disease, but the treatment did not respond (PTA improvement < 15dB).

Exclusion criteria

Exclusion criteria: History of middle ear or inner ear surgery, radiotherapy or chemotherapy; general anesthesia - contraindications.

Design outcomes

Primary

Measure	Time frame
hear level;	—

Secondary

Measure	Time frame
speech recognition rate;	—

Countries

China

Contacts

Public ContactSi Yu

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

siyu5@mail.sysu.edu.cn+86 16620081695

Outcome results

None listed

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