Clinical Research Directory

Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss

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.

Expanded Access Protocol for SPI-1005

The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical trial(s). Adult males and females, age 18 years or older, with Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) who have exhausted available standard-of-care therapies and who may receive benefit from SPI-1005 treatment will be selected to participate in the Expanded Access Protocol, subject to Investigator and Sponsor discretion.

CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial

This exploratory randomized controlled trial evaluates whether a CGM-guided temporary patch pump (CareLevo CSII) reduces glucocorticoid-induced hyperglycemia (GIH) compared to a Lantus-based basal-bolus injection (MDI) regimen in patients with sudden sensorineural hearing loss (SSNHL) and type 2 diabetes or prediabetes receiving high-dose systemic corticosteroids (methylprednisolone 48 mg/day). Patients with SSNHL are treated with high-dose oral corticosteroids as standard of care, which often causes significant postprandial hyperglycemia - particularly in patients with pre-existing diabetes or prediabetes. No randomized trial has investigated the optimal insulin delivery strategy for this specific clinical scenario. All enrolled participants undergo a 2-night inpatient admission (Day 1-3) for safe insulin initiation and device education, followed by outpatient management (Day 4-14). All participants wear a CareSens Air continuous glucose monitor (CGM, 15-day sensor) throughout Day 1-14. Participants meeting insulin activation criteria are randomized 1:1 to: * Arm A (CSII): CareLevo patch pump using a steroid-wave basal profile and carbohydrate-band meal bolus via the app's bolus calculator (CGM-integrated, IOB-adjusted) * Arm B (MDI): Insulin glargine U-100 (Lantus) qAM plus Fiasp prandial bolus via pen using a pre-printed dose table with identical carbohydrate-band algorithm Both arms use identical glycemic targets, carbohydrate-band bolus algorithm (ICR/ISF identical), and correction rules. The primary difference is insulin delivery (patch pump vs. pen injection) and basal profile (steroid-wave CSII vs. flat glargine). The primary outcome is 24-hour CGM Time Above Range (TAR) \>180 mg/dL averaged over the 9-day high-dose steroid period (Day 1-9).

Acupuncture Therapy for Sudden Sensorineural Hearing Loss

The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are: Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture. Participants will: 1. Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks. 2. Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper. 3. Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12. 4. Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.

Intracochlear Injection of Glucocorticoid

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.

'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss

Sudden sensorineural hearing loss (SSNHL) is a medical condition where people experience rapid hearing loss, usually in one ear, over a short period of time (typically within 72 hours). It can affect people of any age, though it is more common among adults aged 40 to 60. In many cases, the exact cause remains unknown, but possible reasons include viral infections, immune-related problems, and reduced blood circulation to the inner ear. Along with hearing loss, many patients may also experience tinnitus (ringing in the ears) or dizziness. The standard treatment for SSNHL often involves steroids, sometimes combined with hyperbaric oxygen therapy. However, the effectiveness of these treatments varies, and many patients do not fully recover their hearing. This study aims to explore whether an additional supplement-'Inner ear support' oral capsule-can improve hearing outcomes and relieve associated symptoms in patients with SSNHL. The study will involve 80 participants who are randomly assigned to two groups. Both groups will receive standard treatment (including steroids and possibly hyperbaric oxygen therapy), but only the test group will take the 'Inner ear support' capsule twice daily for 28 days. Participants will be followed and evaluated over a period of 196 days through hearing tests and symptom questionnaires. 'Inner ear support' is a commercially available nutritional supplement that includes FB-1603 (an extract from Arthrospira maxima), GABA, gamma-oryzanol, and sesamin. Previous research has shown that FB-1603 and its active component, C-phycocyanin, have anti-inflammatory, antioxidant, and nerve-protective effects. Animal studies suggest it may help reduce tinnitus and prevent hearing deterioration. This clinical trial is designed to evaluate whether 'Inner ear support' can enhance hearing recovery, improve tinnitus and dizziness symptoms, and be safely used as an additional treatment in patients with sudden hearing loss. All participants will be monitored for any potential side effects during the study period. The ultimate goal of this study is to determine whether' Inner ear support' could become a helpful addition to current treatment methods for SSNHL, improving patient outcomes and quality of life.

Effect of Hyperbaric Oxygen Therapy(HBOT) on Patients With Sudden Sensorineural Hearing Loss(SSNHL) and Coagulation Function

The objective of this observational study was to understand the effect of HBO on patients with SSNHL and its association with coagulation function and prognosis. The main question it aims to answer is whether HBO therapy can improve outcomes and coagulation function in patients with SSNHL. The prognosis of SSNHL patients receiving HBO and SSNHL patients not receiving HBO were compared

Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss

* To evaluate efficacy of intratympanic injection of dexamethasone and hyaluronic acid mixture as a treatment modality in cases of sudden sensorineural hearing loss (SSNHL). * To compare outcomes of intratympanic injection of dexamethasone and hyaluronic acid mixture to dexamethasone alone in treatment of SSNHL.