The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
This clinical study is prospective, single-center, randomized, controlled, double-blind clinical trail, which entitled transcranial electrical stimulation for the treatment of acute tinnitus approved by Sun Yat-sen University, and intends to recruit 86 patients with sudden deafness and tinnitus. For acute subjective tinnitus, a common otological disease, the study gave the experimental group patients received tDCS with electrodes positioned over the left temporal cortex for 5 days. To assess the efficacy of conventional medical therapy and tDCS by comparing changes in anterior and posterior tinnitus-related subjective scale scores, such as THI, VAS, BAI, BDI, PSQI, and hearing recovery, in patients who received tDCS, to determine whether tDCS is effective in improving acute tinnitus, and whether it is superior to conventional tinnitus treatment. In addition, the study will continue to follow patients for 1 month,3 months, and 6 months after the end of treatment to observe the long-term sustained efficacy of tDCS. This clinical trail will also evaluate tDCS from the perspective of compliance and safety, and explore the factors affecting the efficacy of this therapy.
NCT05964725 — Transcranial Direct Current Stimulation
Status: Recruiting
http://inclinicaltrials.com/transcranial-direct-current-stimulation/NCT05964725/
An Investigator Initiated Study Evaluating the Safety, Tolerability, and Efficacy of OTOV101N+OTOV101C Injection in Treating Patients With OTOF Mutation-related Deafness
This study is an investigator initiated study to evaluate the safety, tolerability, and efficacy of OTOV101N+OTOV101C injection in treating patients with OTOF mutation-related deafness. The enrolled subjects who meet the inclusion and exclusion criteria will receive the gene therapy of OTOV101N+OTOV101C injection via intracochlear injection. All participants will return to the hospital for safety and efficacy evaluations at predetermined time points defined by protocol during the study (Week 1 ± 1 Day, Week 2 ± 3 Days, Week 3 ± 3 Days, Month 1 ± 3 Days, Month 2 ± 3 Days, Month 4 ± 6 Days, Month 6 ± 6 Days, Month 9 ± 6 Days, Month 12 ± 6 Days/EOS (end of study)/unscheduled visit).
NCT05901480 — DFNB9
Status: Recruiting
http://inclinicaltrials.com/dfnb9/NCT05901480/
PET-CT-based Study of Central Mechanisms of Cortical Metabolism in 18F-FDG and 18F-AV1451 Age-related Deafness: a Cross-sectional Study
The participants were recruited from elderly subjects in the age range of 60-85 years and audiological assessments, cognitive function assessments, non-invasive brain imaging, behavioral assessments were collected from the normal control group, the elderly deaf non-hearing group and the elderly deaf hearing group according to the inclusion and exclusion criteria. The project aims to investigate the differences in auditory speech and cognitive function in age-related deafness at the behavioural level, and to investigate the central cortical metabolic mechanisms in age-related deafness at the brain imaging level.
NCT05796011 — Age-related Hearing Loss
Status: Recruiting
http://inclinicaltrials.com/age-related-hearing-loss/NCT05796011/
Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness
Sudden deafness is a sudden, unexplained sensorineural hearing loss of ≥20 dBHL in at least two adjacent frequencies within 72 h. It may be accompanied by tinnitus, a sense of ear congestion, vertigo and other Symptoms.Stellate ganglion block increases the blood flow and blood velocity in the inner ear, keeping the body's vegetative, endocrine and immune functions normal.The branches of the facial and linguopharyngeal nerves are connected to the inner ear, and local injection can nourish the nerves and improve local circulation.
NCT05623384 — Sudden Deafness
Status: Recruiting
http://inclinicaltrials.com/sudden-deafness/NCT05623384/
Correlation Between Peripheral Hearing Loss and Auditory Perception Impairment in Patients With Unilateral Sudden Deafness and Its Underlying Neural Mechanism
At present, few research on the auditory perception function and possible neural mechanisms of unilateral sudden hearing loss patients with complete or partial recovery of peripheral hearing.This project evaluate the speech perception function in noise of unilateral sudden hearing loss patients with with complete and partial hearing recovery by cognitive behavioral experiments, event-related potentials (ERPs) and functional magnetic resonance imaging (fMRI), and longitudinal follow-up to explore its underlying neural mechanisms.
NCT05608161 — Sudden Sensorineural Hearing Loss
Status: Not yet recruiting
http://inclinicaltrials.com/sudden-sensorineural-hearing-loss/NCT05608161/
Longitudinal Study of the Natural History of Two Autosomal Recessive Non Syndromic Deafness (DFNB1A and DFNB9) in Children up to 10 Years of Age
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 10 years of age.
NCT05402813 — Sensorineural Hearing Loss, Bilateral
Status: Recruiting
http://inclinicaltrials.com/sensorineural-hearing-loss-bilateral/NCT05402813/
A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
NCT05318417 — Hearing Loss, Unilateral
Status: Recruiting
http://inclinicaltrials.com/hearing-loss-unilateral/NCT05318417/
Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension in Noise in Bi-implanted Subjects With Post-lingual Deafness
Hearing comprehension under complex listening conditions is considered to be the central complaint of everyday life for patients with cochlear implants. Localization is one of the cues for listening comprehension. However, only few studies have investigated the effect of spatial localization training on listening comprehension performance in noise. None of these studies correspond to the desire to purpose training by speech therapists while using affordable equipment. The main objective of this study is to evaluate the effect of a spatial localization training protocol in cochlear bi-implanted subjects with post-lingual deafness on their ability to understand in noise. 2 groups of 10 subjects each will be recruited: a patient group and a control group. The patient group will undergo 8 sessions of spatial localization rehabilitation lasting an average of 45 minutes each. After this programme, the pre-test and post- test results obtained will be compared.
NCT05237180 — Hearing Loss, Cochlear
Status: Completed
http://inclinicaltrials.com/hearing-loss-cochlear/NCT05237180/
A Prospective, Multi-center, Single-arm, Clinical Investigation of the Safety and Performance of the Sentio System in Users With Mixed/Conductive Hearing Losses and Single Sided Deafness
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.
NCT05166265 — Hearing Loss, Conductive
Status: Active, not recruiting
http://inclinicaltrials.com/hearing-loss-conductive/NCT05166265/
Intraoperative Application of Nimodipine to the Facial and Cochlear Nerves During Vestibular Schwannoma Resection to Avoid Spasm-related Postoperative Facial Paralysis and Deafness - a Prospective Randomized Pilot Study
Title: Intraoperative application of nimodipine to the facial and cochlear nerves during vestibular schwannoma resection to avoid spasm-related postoperative facial paralysis and deafness - a prospective randomized study Background: In patients undergoing microsurgical resection of a vestibular schwannoma, the facial and vestibulocochlear nerves are at risk. Prior studies suggested positive effects of nimodipine for preservation of the nerve function in these patients. A prospective, randomized, placebo controlled double-blinded study will be conducted to evaluate the neuro-protective effect of locally administered nimodipine during resection of vestibular schwannomas. Investigational drug: active group: "Nimotop® 10mg - Infusionsflasche" placebo: "Natrium chloratum physiologicum 0,9% - Medica Infusionslösung" Rationale for the study: Nimodipine is supposed to counteract the vasoconstriction of cerebral arteries caused by microsurgical manipulation and might thereby preserve facial and cochlear nerve function Aims of the study: Evaluation of the effect of intraoperative local administration of nimodipine on the postoperative function of the facial and vestibulocochlear nerves after microsurgical resection of vestibular schwannomas Study design: prospective, double-blinded, single-center, randomized phase III trial Study population: Patients undergoing microsurgical resection of a vestibularis schwannoma with a maximum diameter of 10-25mm on MRI at the Department of Neurosurgery, Medical university of Vienna. Number of Patients: 30 Methods: In 15 patients, nimodipine will be administered locally to the facial and vestibulocochlear nerves during resection of a vestibular schwannoma (= treatment group). In another 15 patients, a placebo (sodium chloride solution) will be administered. In both cases, a soaked gel foam pad will be used. The operating team and the patient will both be blinded during the procedure. Facial nerve function and hearing will be assessed prior and three months after surgery. Outcome variables: Serviceable or non-serviceable hearing according to Gardner-Robertson hearing scale and House-Brackmann score for the assessment of facial nerve function Statistical analysis: For the evaluation of the postoperative function of the vestibulocochlear nerve, the number of patients with postoperative serviceable hearing (Gardner-Robertson I-II) and postoperative non-serviceable hearing (Gardner-Robertson III-V) will be compared between both groups. For the evaluation of the facial nerve function, the number of patients with favorable postoperative outcome (House-Brackmann I-III) and non-favorable postoperative outcome (House-Brackmann IV-VI) will be compared. In both cases, fisher's exact test will be used. Expected risks/inconveniences: Administration of nimodipine is associated with the following adverse effects: thrombocytopenia, allergic reactions, headache, tachycardia, hypotension, nausea (occasionally) and bradycardia, ileus, reversibly elevated liver enzymes (seldom) Risk/benefit assessment: Expected adverse effects of local nimodipine administration are manageable and patients may profit from the use of nimodipine. No severe adverse events are expected.
NCT04801953 — Vestibular Schwannoma
Status: Recruiting
http://inclinicaltrials.com/vestibular-schwannoma/NCT04801953/