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NCT Number: NCT07540728

Trans-round Window Membrane Intracochlear Steroid

Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss

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Key information

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fenyang Road 83

Shanghai, Shanghai Municipality, 200031, China

Location contact

Huawei Li, MD, Ph.D

PRINCIPAL_INVESTIGATOR

Wei Li, MD, PhD

CONTACT

[email protected]

0086-18301969566

Wuqing Li, MD, Ph.D

PRINCIPAL_INVESTIGATOR

Yilai Shu, MD, Ph.D

PRINCIPAL_INVESTIGATOR

About this study

The main questions it aims to answer are:

  • Whether is it safe when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
  • Whether is it effective in reversing hearing capability when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
  • Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating profound or complete sudden sensorineural hearing loss.
  • Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 12 and 75 years Unilateral idiopathic sudden sensorineural hearing loss diagnosed by Pure tone test, CT and MRI Symptoms of sudden deafness occur within ≥ 7 days and, after conventional treatment, the average thresholds at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz are ≥ 80 dBHL

Exclusion criteria

  • Bilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.

History of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency

Treatment and study plan

Experimental: Group A: intracochlear triamcinolone acetonide injection

Drug

intracochlear injection of triamcinolone acetonide through the round window membrane

intracochlear injection of dexamethasone

Drug

intracochlear injection of dexamethasone through the round window membrane

intratympanic dexamethasone injection

Device

intratympanic dexamethasone injection through tympanic membrane

Primary outcomes

  1. Change from Baseline in pure tone audiometry (PTA)

    Time frame: Baseline, Week12,

    hearing capacity of thresholds ( PTA)

  2. Change from Baseline in Speech Discrimination Scores

    Time frame: Baseline, Week12

    hearing capacity of thresholds ( speech discrimination )

Secondary outcomes

  1. Change from Baseline in auditory brainstem re-sponse (ABR)

    Time frame: Baseline, Week12

    hearing capacity of thresholds ( ABR)

  2. Change from Baseline in auditory steady-state response (ASSR)

    Time frame: Baseline, Week12

    hearing capacity of thresholds (ASSR)

  3. change from baseline in tinnitus handicap inventory

    Time frame: Baseline, Week2, Week4, Week12, Week24

    The scales assess changes in vertigo

  4. change from baseline in dizziness handicap inventory

    Time frame: Baseline, Week2, Week4, Week12, Week24

    The scales assess changes in vertigo

  5. change from baseline in quality of life score

    Time frame: Baseline, Week2, Week4, Week12, Week24

    The scales assess changes in quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Li, MD, Ph.D

CONTACT

[email protected]

0086-18301969566

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Collaborators

  • Shanghai Zhongshan Hospital
  • Shenzhen Second People's Hospital

Registry information

Official study title

Efficacy and Safety of Trans-Round Window Membrane Intracochlear Steroid Delivery in Patients With Complete Sudden Sensorineural Hearing Loss

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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