The efficacy and safety of glucocorticoid treatment by efficient delivery via the round window in total sudden deafness: an open-label, multicenter, superiority, randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400091078

Enrollment

Unknown

Registered

2024-10-21

Start date

2024-10-21

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Sudden sensorineural hearing loss

Interventions

Control group:Local dexamethasone therapy (5m/d for 7 days) via tympanic membrane puncture and intratympanic injection.

Experimental group:Efficient delivery of dexamethasone (5m/d for 7 days) via the round window, following the round window niche surgery.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 75 years old; 2. According to the AAO-HNS clinical practice guideline, diagnosed with unilateral total sudden deafness: a full-frequency profound sensorineural hearing loss occurred within 72 hours, and the average pure tone hearing threshold of 0.5KHz, 1kHz, 2KHz, 4kHz was greater than 80dB; Diagnosis of sudden deafness is supported by physical examination, pure tone audiometry, acoustic impedance, ABR, etc., with or without ear tightness, tinnitus, periauricular numbness, dizziness, vertigo, etc; 3.Within a 2-week window from symptom onset, and systemic or intratympanic corticosteroids has not been taken; 4. Temporal bone CT- based imaging assessment suggests anatomical abnormalities of the round window niche: the entrance of the round window niche is stenotic or obstructed by soft tissu,; 5.Voluntary participation in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.With sensorineural hearing loss due to other defined otologic diseases such as drug ototoxicity, trauma, structural or retrocochlear lesion, Meniere's disease, congenital hearing loss, malignant tumors, etc; 2.With a surgery history on the middle or inner ear; 3.Contraindications to surgery, severe liver and kidney diseases; 4.Special populations such as pregnant and lactating women; 5.The investigator deemed it inappropriate for this trial.

Design outcomes

Primary

Measure	Time frame
Hearing improvement rate;	—

Secondary

Measure	Time frame
Pure-tone audiometry;Word recognition score;	—

Countries

China

Contacts

Public ContactSi Yu

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

siyu5@mail.sysu.edu.cn+86 166 2008 1695

Outcome results

None listed

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