Fenyang Road 83
Shanghai, Shanghai Municipality, 200031, China
Location contact
Huawei Li, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Wei Li, MD, PhD
CONTACT
Wuqing Li, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Yilai Shu, MD, Ph.D
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07540728
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
Trial opening soon.
Get Notified12 year–75 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200031, China
Huawei Li, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Wei Li, MD, PhD
CONTACT
Wuqing Li, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Yilai Shu, MD, Ph.D
PRINCIPAL_INVESTIGATOR
The main questions it aims to answer are:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
intracochlear injection of triamcinolone acetonide through the round window membrane
intracochlear injection of dexamethasone through the round window membrane
intratympanic dexamethasone injection through tympanic membrane
Time frame: Baseline, Week12,
hearing capacity of thresholds ( PTA)
Time frame: Baseline, Week12
hearing capacity of thresholds ( speech discrimination )
Time frame: Baseline, Week12
hearing capacity of thresholds ( ABR)
Time frame: Baseline, Week12
hearing capacity of thresholds (ASSR)
Time frame: Baseline, Week2, Week4, Week12, Week24
The scales assess changes in vertigo
Time frame: Baseline, Week2, Week4, Week12, Week24
The scales assess changes in vertigo
Time frame: Baseline, Week2, Week4, Week12, Week24
The scales assess changes in quality of life
Contact information is provided by the study sponsor or research team.
Eye & ENT Hospital of Fudan University
Other
Efficacy and Safety of Trans-Round Window Membrane Intracochlear Steroid Delivery in Patients With Complete Sudden Sensorineural Hearing Loss
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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