A Phase 3 interventional study of autologous circulating extracellular vesicles and Glucocorticoids in Sudden Sensorineural Hearing Loss (SSNHL), sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 3, Interventional, and Treatment
Total-type sudden sensorineural hearing loss (defined in this study as severe-to-profound sudden sensorineural hearing loss with pure-tone average (PTA) >70 dB HL) represents one of the poorer-prognosis subtypes of sudden sensorineural hearing loss (SSNHL). It is characterized by severe or profound sensorineural hearing decline occurring within 72 hours, frequently accompanied by tinnitus, aural fullness, vertigo and other symptoms. Although glucocorticoid-based comprehensive therapy has been widely applied in clinical practice, overall prognosis remains unsatisfactory for patients with total-type SSNHL, with low hearing recovery rates. Long-term hearing loss impairs verbal communication, sound source localization and quality of life, and is also associated with anxiety, depression and cognitive decline. Some patients further require hearing rehabilitation with hearing aids or auditory implantation, imposing substantial psychological and economic burdens on individuals and families. Therefore, exploring safer and more innovative therapeutic strategies carries important clinical significance.
Extracellular vesicles (EVs) therapy is an emerging cell-free therapeutic technology. Previous pre-clinical studies have demonstrated that EVs can ameliorate inner-ear injury via anti-inflammatory, anti-oxidative-stress and neuroprotective effects, showing promising therapeutic potential in animal models of noise-induced and ototoxic drug-induced hearing loss. The investigators' prior research revealed that EV treatment effectively preserved hearing and alleviated cochlear damage in noise-deafened mice. Meanwhile, the investigators have completed a prospective, randomized exploratory clinical trial (NCT06707389). Its results indicated that intratympanic injection of extracellular vesicles (EVs) yielded favorable safety profiles in total-type SSNHL, without serious adverse events observed, and demonstrated a trend toward superior clinical benefits over conventional therapy in terms of hearing recovery and speech recognition improvement.
Based on the above evidence, the investigators intend to conduct a multicenter, prospective, superiority-design randomized controlled clinical trial enrolling 146 patients with total-type SSNHL. This study will systematically evaluate the efficacy and safety of intratympanic autologous circulating extracellular vesicles (C-EVs) combined with glucocorticoid therapy, so as to provide new evidence-based medical data and therapeutic options for total-type SSNHL.
49 studies on the registry are indexed under Hearing Loss, Sudden; 21 are open to participants now.
This study's planned enrollment of 146 is above the median of 72 across 39 interventional studies indexed under Hearing Loss, Sudden.
Browse Hearing Loss, Sudden studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 477 studies on the registry; 278 are open to participants now.
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Exclusion Criteria:
Peripheral blood (20 mL) is collected from patients to isolate autologous circulating extracellular vesicles (C-EVs), including plasma-derived EVs and PBMC-derived EVs. The vesicles are resuspended in a mixture consisting of 0.2 mL lidocaine injection containing 40 mg methylprednisolone and 0.8 mL sterile water for injection for intratympanic administration. The injection volume is 1.0 mL, administered once every other day for a total of three times over a one-week treatment course.
Drug: autologous circulating extracellular vesicles · Drug: Glucocorticoids
Intratympanic injection of methylprednisolone sodium succinate for injection (trade name: Solu-Medrol) at a concentration of 40 mg/mL. For preparation, 40 mg of methylprednisolone sodium succinate is reconstituted with 0.2 mL lidocaine injection and 0.8 mL sterile water for injection. The prepared methylprednisolone solution is administered intratympanically at an injection volume of 1.0 mL, once every other day for a total of three doses within a one-week treatment course.
Drug: Glucocorticoids
Intratympanic injection of autologous circulating extracellular vesicles combined with glucocorticoids
Intratympanic injection of glucocorticoids
The proportion of subjects whose pure-tone average (PTA) hearing threshold improved by >10 dB from baseline at 1 month after treatment
According to the Clinical Practice Guideline: Sudden Hearing Loss (2019) from the United States, hearing improvement is defined as an increase of more than 10 dB in pure-tone hearing threshold relative to baseline. The hearing improvement rate refers to the proportion of patients with a pure-tone hearing threshold increase of more than 10 dB, which is an objective qualitative indicator. Measured population: All subjects Measurement time points: Baseline, 1 month after treatment Evaluator: Otological Function Laboratory of the participating hospital
Time frame: Baseline, 1 month after treatment
pure-tone hearing threshold
The difference in pure-tone audiometric thresholds is obtained by pure-tone audiometry. The definition, study subjects, time points and assessor for pure-tone audiometry are the same as described above.
Time frame: Assessment time points: 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
speech recognition score (SRS)
Speech recognition score is measured by speech audiometry. Speech audiometry is an audiometric method that uses standardized speech signals as acoustic stimuli to test subjects' speech recognition ability. Clinical test parameters include: speech recognition scores of subjects at specific speech intensities (e.g., 50, 65, 80 dB SPL representing soft, moderate and loud everyday speech levels); maximum speech recognition score (generally corresponding to intensity at speech-recognition threshold or 30-40 dB HL above pure-tone average threshold). At varying speech intensities, multiple equivalent test lists are administered sequentially to obtain the function curve of speech-recognition score versus intensity, and to derive the dynamic range of speech intensity corresponding to 20%-80% speech-recognition score.
Time frame: Assessment time points: Baseline, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
Tinnitus Handicap Inventory (THI)
The total THI score ranges from 0 to 100 points, divided into five grades: Grade I (slight tinnitus): 0-16 points; Grade II (mild tinnitus): 18-36 points; Grade III (moderate tinnitus): 38-56 points; Grade IV (severe tinnitus): 58-76 points; Grade V (catastrophic tinnitus): 78-100 points. Success criterion: A decrease of 15 points or more in post-treatment THI compared with pre-treatment THI.
Time frame: Assessment time points: Baseline, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
Degree of ear fullness
The degree of ear fullness is assessed by the Visual Analogue Scale (VAS). Scores range from 0 to 10 points: 0 = no ear fullness, 10 = most severe ear fullness. Higher scores indicate more severe ear fullness. Study subjects: All subjects
Time frame: Assessment time points: Baseline, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
vertigo severity
Vertigo severity is evaluated using the Dizziness Handicap Inventory (DHI). Total DHI scores range from 0 to 100 points; higher scores indicate greater impact of vertigo on daily activities. Study subjects: Subjects with concomitant vertigo symptoms
Time frame: Assessment time points: Baseline, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
quality of life (QoL)
Health-related quality of life is assessed using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) to evaluate changes in subjects' health-related quality of life before and after treatment. Study subjects: All subjects
Time frame: Assessment time points: Baseline, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
Tinnitus Visual Analogue Scale (VAS)
The VAS score ranges from 0 to 10 points; 0 indicates no discomfort, and 10 indicates severe discomfort. VAS is classified into three grades: mild (0-3 points), moderate (4-7 points), severe (8-10 points). A VAS score \>5 indicates that tinnitus has impaired quality of life. Success criterion: A decrease of 1 point or more in post-treatment VAS compared with pre-treatment VAS.
Time frame: Assessment time points: Baseline, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
Safety Indicators
Safety evaluation focuses primarily on treatment-related adverse events and serious adverse events, with special attention to local and systemic reactions potentially associated with intratympanic injection and autologous PBMC-EVs therapy. 1. Local adverse events: including injection-related pain, transient vertigo, aggravated tinnitus, aggravated ear fullness, persistent unhealed tympanic membrane perforation, middle-ear infection, otorrhea, tympanic effusion, and further deterioration of hearing after treatment. 2. Systemic adverse events: including fever, allergic reactions, vagal reflex, and other systemic discomforts judged by investigators to be possibly related to study intervention. 3. Serious adverse events: including death, life-threatening events, hospitalization or prolonged hospitalization, and events resulting in permanent or severe functional impairment. Subjects for safety indicator assessment: All study subjects.
Time frame: Investigators shall perform safety assessments via medical history inquiry, otoscopic examination, vital-sign monitoring, and pure-tone audiometry at each treatment and follow-up visit.
Evaluation of peripheral-blood inflammatory and nutritional status.
Peripheral-blood levels of neutrophils, lymphocytes, monocytes, albumin and total cholesterol will be measured. The neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), and Naples Prognostic Score (NPS) will be calculated to analyze their correlations with hearing recovery and speech recognition improvement.
Time frame: Baseline and 7 days after treatment.
Quality evaluation of PBMC-derived extracellular vesicles
Routine quality assessments including particle-size distribution will be performed for each batch of PBMC-EVs. Representative batches will be tested for canonical extracellular-vesicle markers and other biological characteristics to explore their associations with clinical efficacy.
Time frame: Baseline and 7 days after treatment.
Biobank establishment
Peripheral-blood specimens (PBMCs, plasma and serum) will be collected and stored from subjects before and after treatment.
Time frame: Baseline and 7 days after treatment.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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