Sudden Sensorineural Hearing Loss (SSNHL)Phase 3NCT07878559
Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
A Phase 3 study testing autologous circulating extracellular vesicles and Glucocorticoids in people with Sudden Sensorineural Hearing Loss (SSNHL), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Sensorineural Hearing Loss (SSNHL)
- What is being tested?
- autologous circulating extracellular vesicles and Glucocorticoids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to 31 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old;
- Patients with unilateral severe or profound hearing loss (>70 dB HL) meeting the diagnostic criteria recommended by the Clinical Practice Guideline: Sudden Hearing Loss (2019) (United States);
- Onset of sudden sensorineural hearing loss within 3 weeks;
- Patients fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, sign the written informed consent form, and are willing to complete the entire trial process in accordance with trial requirements;
- Enrolled patients shall receive inpatient treatment; for patients unable to be hospitalized, all clinical examination data must be complete;
- All patients must have signed the informed consent form.
Who cannot join
- The affected ear has other deafness-causing factors, such as lateral skull-base tumor, trauma, drug ototoxicity, etc.;
- Patients with concurrent conductive hearing loss or mixed hearing loss in the affected ear;
- Patients with other comorbidities of the affected ear or pre-existing hearing loss;
- Sudden unilateral or sequentially bilateral hearing loss (onset within several minutes to 3 days);
- Patients with doubts about the treatment regimen or significant psychological-psychiatric disorders;
- Patients with severe cardiac, pulmonary, hepatic or renal dysfunction, or those deemed unsuitable for this study by physician assessment;
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- Patients with middle-ear lesions, Ménière's disease, vestibular schwannoma, large vestibular aqueduct syndrome and other related diseases are excluded;
- Patients with a history of infection within 1 month prior to screening requiring hospitalization and/or antibiotic therapy, or those currently receiving systemic glucocorticoids, immunosuppressants or cytotoxic therapy;
- Women who are lactating, pregnant or planning to become pregnant;
- Patients with contraindications or allergies to the study treatment;
- Other patients unsuitable for intratympanic injection therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Otoendoscope
Guangzhou, Guangdong, 510000
Jiaqi Pang, Doctor, 86+13512722134, 54331601@qq.com
Haidi Yang, Doctor, 86+13178821663, yanghaidi1978@163.com
About this study
Official title: Comparison of Efficacy and Safety of Intratympanic Injection of Autologous Circulating Extracellular Vesicles Plus Glucocorticoid Versus Glucocorticoid Monotherapy for Total-Type Sudden Sensorineural Hearing Loss: A Multicenter, Superiority, Randomized Controlled Clinical Trial
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.
- Being tested
- autologous circulating extracellular vesicles, Glucocorticoids
- Keywords
- total-type sudden sensorineural hearing loss, intratympanic injection, glucocorticoids, circulating extracellular vesicles (c-EV)
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous circulating extracellular vesiclesDrug
Intratympanic injection of autologous circulating extracellular vesicles combined with glucocorticoids
GlucocorticoidsDrug
Intratympanic injection of glucocorticoids
| Study group | Role | What they receive |
|---|---|---|
| c-EVs plus glucocorticoids | Experimental | 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. Receives: Drug: autologous circulating extracellular vesicles; Drug: Glucocorticoids |
| glucocorticoids | Active comparator | 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. Receives: Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1 month after treatment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Assessment time points: Baseline, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing Loss (SSNHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Haidi Yang, Doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878559
- Sponsor's protocol ID
- SYSKY-2025-911-02
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Intratympanic Injection of Autologous Circulating Extracellular Vesicles Plus Glucocorticoid Versus Glucocorticoid Monotherapy for Total-Type Sudden Sensorineural Hearing Loss: A Multicenter, Superiority, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07878559
- Acronym / sponsor ID
- SYSKY-2025-911-02
- Keywords
- total-type sudden sensorineural hearing loss, intratympanic injection, glucocorticoids, circulating extracellular vesicles (c-EV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| c-EVs plus glucocorticoids | Experimental | Drug: autologous circulating extracellular vesicles, Drug: GlucocorticoidsPeripheral 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. |
| glucocorticoids | Active comparator | Drug: GlucocorticoidsIntratympanic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years old;
- Patients with unilateral severe or profound hearing loss (>70 dB HL) meeting the diagnostic criteria recommended by the Clinical Practice Guideline: Sudden Hearing Loss (2019) (United States);
- Onset of sudden sensorineural hearing loss within 3 weeks;
- Patients fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, sign the written informed consent form, and are willing to complete the entire trial process in accordance with trial requirements;
- Enrolled patients shall receive inpatient treatment; for patients unable to be hospitalized, all clinical examination data must be complete;
Key exclusion criteria (11 listed)
- The affected ear has other deafness-causing factors, such as lateral skull-base tumor, trauma, drug ototoxicity, etc.;
- Patients with concurrent conductive hearing loss or mixed hearing loss in the affected ear;
- Patients with other comorbidities of the affected ear or pre-existing hearing loss;
- Sudden unilateral or sequentially bilateral hearing loss (onset within several minutes to 3 days);
- Patients with doubts about the treatment regimen or significant psychological-psychiatric disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous circulating extracellular vesiclesIntratympanic injection of autologous circulating extracellular vesicles combined with glucocorticoids | Drug | c-EVs plus glucocorticoids |
| GlucocorticoidsIntratympanic injection of glucocorticoids | Drug | c-EVs plus glucocorticoids, glucocorticoids |
Primary outcome
The proportion of subjects whose pure-tone average (PTA) hearing threshold improved by >10 dB from baseline at 1 month after treatment
Time frame: Baseline, 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
7 secondary outcomes
pure-tone hearing threshold
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)
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)
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
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
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)
Time frame: Assessment time points: Baseline, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
Tinnitus Visual Analogue Scale (VAS)
Time frame: Assessment time points: Baseline, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haidi Yang, Doctor principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing autologous circulating extracellular vesicles and Glucocorticoids in people with Sudden Sensorineural Hearing Loss (SSNHL), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaqi Pang, Doctor (86+13512722134, 54331601@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects whose pure-tone average (PTA) hearing threshold improved by >10 dB from baseline at 1 month after treatment (time frame: Baseline, 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.