Hydrogen-oxygen Gas Mixture Inhalation in Patients With Sudden Sensorineural Hearing Loss
Hearing LossSensorineuralIdiopathic sudden sensorineural hearing loss (ISSHL) is defined according to American Academy of Otolaryngology as a hearing loss of at least 30 decibel over 3 contiguous test frequencies occurring within a 72h period. It affects 5 to 20 people per 100,000 annually and is characterized by sudden-onset, generally unilateral, sensorineural hearing loss. Its cause is idiopathic in most of the patients; however, vascular disorders have been proposed as the final common pathway. Recent studies have reported that the impaired microvascular perfusion occurring during an ischemic event may be related to oxidative stress which may be synergistically responsible for endothelial damage, especially in terminal microvascular systems. Hydrogen, which serves as a free radical scavenger and can reduce the strong oxidants, is found as a therapeutic gas in cochlea in recent studies. Both antioxidant and anti-inflammatory effects have been seen with hydrogen administration in animal models. Since cisplatinum toxicity and acoustic trauma both involve oxidative stress to the cochlea, hydrogen may prove useful in these conditions. The efficacy and safety of hydrogen inhalation are also proved in clinical studies. Given the theories mentioned above, the purpose of our study is to use inhaled hydrogen as an adjuvant therapy for treating idiopathic sudden sensorineural hearing loss. The systemic inflammation status and oxidative stress will be monitored. Both subjective and objective efficacy after treatment will be assessed.
Assess Specific Kinds of Children Challenges for Neurologic Devices Study
Primary DystoniaEpilepsy3 moreThe ASK CHILDREN study is intended to aid in future development of various neurologic devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to identify more efficient strategies in the evaluation and review of neuroprostheses regulated by the Agency.
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
Sudden Loss of Hearingsudden sensorineural hearing loss: idiopathic in most cases 5-20/100,000 new cases annually in the U.S no establishes pathogenesis treated with oral steroids in most cases ~50% improvement in hearing levels bed rest - acceptable treatment, not well investigated
Comparing Site-selection Strategies
DeafnessSeveral studies in the past have tried to deactivate electrodes that are less optimal to improve speech recognition outcomes. The study aims to compare the measures based on which the deactivation was performed. The investigators aim to first examine if the measures are strongly correlated each other, and then compare the deactivation effects across measures. These measures are mainly behavioral including electrode discrimination, amplitude modulation detection thresholds, low-rate and focused detection thresholds and electrode-modiolus distance. The endpoint of the study is speech recognition performance post deactivation.
Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation...
Hearing LossSudden3 moreTo study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.
Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled...
Chronic Otitis Media With EffusionConductive Hearing LossThe purpose of our double-blind, placebo controlled study is to test the hypothesis that montelukast therapy might be associated with improved hearing in certain sub populations of children suffering from OME.
Prevention of Noise-induced Hearing Loss
Noise-induced Hearing LossNoise-induced hearing loss affects an estimated 5% of the worldwide population, with 30-40 million Americans exposed to hazardous sound or noise levels regularly. Sources of noise may be occupational, blast noise, or recreational. Trauma to the inner ear can occur through transient hearing loss or permanent hearing loss. Although hearing recovers after temporary transient hearing loss, growing evidence suggests that repeated temporary transient hearing loss may lead to a permanent hearing loss. Currently, there are no treatments and there are no known medications that can be used clinically to prevent noise-induced hearing loss in humans. The long-term goal of this research is to find medications that can prevent noise-induced hearing loss. The purpose of the present pilot study is to evaluate zonisamide and methylprednisolone as medications to prevent temporary transient hearing loss in humans.
A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Noise Induced Hearing LossSPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
Lung CancerHead and Neck Cancer4 moreChemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.
Middle-Ear Implant With MET V Transducer (Aka MET V System)
Mixed Conductive and Sensorineural Hearing LossBilateralThe purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.