NCT Number: NCT07134075
This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200031, China
Haibo Shi, MD, Ph.D
SUB_INVESTIGATOR
Huawei Li, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Wei Li, MD, PhD
CONTACT
Wuqing Wang, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Xinsheng Huang, MD, Ph.D
SUB_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
Age between 18 and 65 years Unilateral idiopathic sudden sensorineural hearing loss greater than 95dB at the average of 4 frequencies (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) in PTA (contralateral hearing is less than 30dB) at the onset of sudden hearing loss Participant who were treated with standard treatment for 14 days, but no recovery was confirmed as type IV (final hearing level with hearing gain of ≤15 dB) at the end of the 14-day treatment
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 The CT diagnosis is "abnormality of the round window niche"
intracochlear triamcinolone acetonide injection of through the round window membrane
Other names: intracochlear triamcinolone acetonide （40mg/ml, 30μl）injection
intracochlear injection of dexamethasone sodium phosphate through the round window membrane
Other names: intracochlear injection of dexamethasone sodium phosphate（7.5mg/ml, 30μl）through the round window membrane
intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane
Other names: intracochlear injection of dexamethasone sodium phosphate through the round window membrane (7.5mg/ml, 30μl) and intratympanic dexamethasone sodium phosphate injection (10mg/ml)
intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections.
Other names: intratympanic dexamethasone sodium phosphate injection (10mg/ml)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (PTA)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (ABR)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (ASSR)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (speech Discrimination Scores)
Time frame: Baseline, Week2, Week4, Week12, Week24
The THI questionnaire includes functional, emotional, and catastrophic subscales. It consists of 25 questions. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Time frame: Baseline, Week2, Week4, Week12, Week24
The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).
Time frame: Baseline, Week2, Week4, Week12, Week24
Quality of life questionnaire will be measured to compare the change in individual's health-related quality of life using face to face Interview for the scores. Higher scores mean better functioning or fewer symptoms.
Contact information is provided by the study sponsor or research team.
Eye & ENT Hospital of Fudan University
Other
Safety and Efficacy of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Total 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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