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Showing 1-10 of 10 trials
NCT07067801
Context: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is a rapid-onset, sensorineural hearing loss of unknown etiology. It is one of the most common ENT emergencies, with spontaneous recovery occurring in 32% to 65% of cases. Treatment remains controversial, and the need for treatment itself is debated. Oral corticosteroids (OCS) are commonly used as first-line therapy, although they may have short-term side effects. Intratympanic corticosteroid injections (ITCIs) are an option for patients with contraindications to OCS or as a salvage treatment. The most recent Cochrane review includes three placebo-controlled studies on OCS efficacy (totaling 267 patients): two found no superiority of OCS, while one showed improvement in hearing. These studies are inconsistent and present methodological biases. Therefore, a sufficiently powered study is needed to assess OCS efficacy and establish clear treatment recommendations for ISSHL. Objectives: Primary Objective: To demonstrate the equivalence of OCS as first-line treatment for ISSHL compared to no treatment, in terms of hearing recovery between days 7 and 10. Secondary Objectives: To assess the effect of OCS versus no treatment on tinnitus, and hearing recovery based on initial severity of ISSHL. To evaluate hearing recovery in patients treated with rescue ITCIs. In the absence of equivalence, to investigate the superiority of OCS over no treatment. Methods: This multicenter, randomized, controlled equivalence trial will include two arms, each with 215 patients: one receiving OCS and the other a no-treatment control. In the absence of early hearing improvement, ITCIs will be administered regardless of study arm. Perspective: The goal is to clarify the role of OCS in treating ISSHL and guide the development of updated treatment recommendations.
NCT07045883
Clinical Trial Protocol: Investigating the Therapeutic Efficacy of Vitamin D in ISSNHL。Core Research Questions Can vitamin D supplementation improve the prognosis of Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)? What potential medical issues might arise during vitamin D administration? Study Design A controlled trial comparing: Intervention group: Vitamin D supplementation + standard care Control group: Standard care alone Participant Procedures Baseline assessment: Venous blood draw (2 mL) for 25(OH)D level measurement. intervention phase:Daily vitamin D supplementation for 1 month Endpoint evaluation (1-month follow-up): Repeat audiometric testing (pure-tone audiometry). Post-treatment 25(OH)D concentration analysis.
NCT06997406
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.
NCT06819202
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
NCT06878599
* 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.
NCT06365775
The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are: * if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls * if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls * to find out which factor from multi-omics data relates to outcomes of SSNHL * to develop the best prognostics model based on the multi-omics data. Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.
NCT06278129
Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.
NCT04120116
This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
NCT04224909
The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test
NCT02483650
The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world patient outcome and side effect information from electronic health records submitted to a specialty specific hyperbaric registry as part of "Stage 2 of Meaningful Use," including data provided to meet PQRS requirements via the registry's QCDR mission. Goals include understanding the value of HBOT among patients treated for a variety of conditions in relation to the frequency and severity of HBOT side effects. While randomized, controlled trials can establish the efficacy of treatments like HBOT, because they routinely exclude patients with co-morbid conditions common to those patients seen in usual clinical practice, the results of RCTs are usually non-generalizable. Real world data can be used to better understand the effectiveness of HBOT among typical patients, as well as the risks associated with treatment.