Labyrinthitis

Researchers are evaluating the safety, tolerability, and effectiveness of the gene therapy SENS-501 in children aged 6 to 31 months who have severe to profound hearing loss caused by mutations in the Otoferlin gene. This open-label Phase I/II study focuses on children with pre-lingual hearing loss due to these genetic mutations, aiming to better understand how this treatment works in this young population. The study involves administering SENS-501 directly into one ear using a special injection system. It includes a dose-escalation phase where children receive either a low or high dose, followed by a dose expansion phase where the dose recommended from earlier phases is given. The treatment is given as a single unilateral intracochlear injection, and the administration system's safety, performance, and usability are also evaluated. Participants will be followed for up to 5 years to monitor safety and tolerability and to assess hearing improvement using auditory brainstem response (ABR) and pure tone audiometry (PTA). Additional evaluations include clinical checks of the administration system shortly after treatment. Throughout the study, children will undergo hearing tests and medical assessments to measure outcomes and track any side effects or complications from the treatment and procedure.

Researchers are investigating the use of Clemastine Fumarate combined with engineered sound to treat age-related central auditory processing disorder (CAPD), a condition affecting many people over 40 and causing difficulty hearing in noisy environments. This trial aims to test if the therapy, called Localized Oligodendrocyte Optimization Therapy (LOOT), which showed promise in animal studies, can improve hearing in noise for humans. The study is designed to compare the effectiveness of the drug with or without engineered sound in a controlled, randomized setting. Participants will be randomly assigned to one of four groups: Clemastine Fumarate with engineered sound, Clemastine Fumarate with placebo sound (white or pink noise), placebo drug with engineered sound, or placebo drug with placebo sound. The drug dosage is carefully controlled and given orally over 30 days, while participants listen to the assigned sound stimulation through headphones for one hour daily. The trial includes an adaptive design allowing adjustment of study arms based on interim results. Throughout the study, participants will undergo hearing tests to measure their ability to hear in noisy environments, both before and after treatment. Additional assessments include questionnaires on speech and tinnitus, auditory brainstem response tests, physical exams, blood tests, and EKGs to monitor health and safety. The treatment period lasts one month, with evaluations scheduled around weeks five or six. Safety and hearing improvements are carefully monitored to assess the therapy's impact.

Researchers are evaluating a combined therapy called Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for individuals aged 18 to 49 who have vestibular symptoms related to mild traumatic brain injury (mTBI). This trial compares ACTIVE with usual care vestibular rehabilitation (VESTIB CONTROL) to see which approach better reduces symptoms and improves recovery. The study focuses on military service members and civilians who experience ongoing dizziness and related impairments after mTBI. Participants in the ACTIVE group will receive four weekly 90-minute sessions combining Acceptance and Commitment Therapy (ACT) and targeted vestibular rehabilitation exercises, along with daily at-home activities over four weeks. The ACT component focuses on psychological flexibility and mindfulness. The comparison group will receive usual care vestibular rehabilitation and other supportive treatments excluding ACT, also delivered weekly over four weeks. Both groups will have individualized care based on their needs. Participants will be assessed before treatment and at 4 weeks, 3 months, and 6 months after treatment ends. Assessments include dizziness severity, anxiety levels, vestibular function tests, symptom questionnaires, and activity monitoring using Fitbit devices. Researchers will monitor symptoms, functional improvements, and return to activity status. The total participation period covers about six months, allowing for evaluation of both short- and longer-term outcomes.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Researchers are investigating auditory functions in patients with Multiple Sclerosis (MS) by using various hearing tests and analyzing cerebrospinal fluid (CSF) for inflammatory markers. This observational case-control study compares healthy adults and adults with Relapsing Remitting MS, aiming to find correlations between auditory test results and CSF findings to better understand hearing issues related to MS. Participants will undergo several auditory tests including Pure Tone Auditory test, Tympanometry, Stapedial Reflex, Speech Perception test, and if applicable, tinnitus-related questionnaires and acuphenometry. Additionally, Distortion Product Otoacoustic Emissions (DPOAEs) and Auditory Brain Response (ABR) tests will be performed. CSF will be collected via lumbar puncture for analysis. MRI tractography is performed if hearing impairment is detected. Participants' involvement includes screening through medical records, MRI scans, blood tests, and hearing loss questionnaires. They will undergo the auditory tests and CSF sampling as described. Researchers will measure auditory function and its correlation with CSF results over 12 months. The study includes healthy volunteers and MS patients aged 20 to 40 years, with ongoing monitoring of auditory function and neurological status.

Researchers are investigating disorders affecting the head and neck to improve understanding and aid in developing better treatments. This observational study aims to create a biorepository of both diseased and normal tissue samples from individuals with head and neck conditions. The research is conducted by the National Cancer Institute and focuses on collecting valuable biological materials for future studies related to these disorders. Participants diagnosed with head and neck conditions can contribute by allowing leftover tissue samples from their clinical care or previous research to be stored for study. The study has two parts: Part 1 involves sharing surgical waste specimens for research, while Part 2 includes additional sample collection such as blood draws, cheek swabs, saliva collection, and, for adults 18 and older, optional skin or mucosal biopsies. No experimental treatments are given during this study. During the study, participants will undergo screening including questionnaires, medical history review, and physical exams. Samples collected will be used for genetic and molecular research. The primary outcome is to establish a repository of tissue specimens by December 2026. Participant involvement may include providing permission for sample use, additional sample collection, and ongoing sharing of specimens for approved research projects. The study continues to share samples for cellular and genetic analysis to support future research on head and neck disorders.

Researchers are conducting an observational study to analyze physical condition abnormalities, mental health, and blood test results in patients with benign paroxysmal positional vertigo (BPPV). The study also aims to create a brain MRI database to identify patients at high risk of residual dizziness and develop a comprehensive system for diagnosing, treating, and recovering from residual dizziness in China. Participants include confirmed BPPV patients and healthy individuals without BPPV. Both groups will undergo behavioral and psychological assessments, blood sample collection, and three brain MRI scans—at the start of the study, and again one month and six months after treatment for BPPV patients. Healthy controls complete these assessments only once at inclusion. During the study, participants will fill out psychological questionnaires, provide blood samples at a local lab, and receive brain MRI scans. Researchers will monitor differences in brain structure and function, vertigo symptoms, and blood markers over time. Additional assessments include fatigue, sleep, cognition, executive function, anxiety, depression, verbal memory, working memory, and auditory attention. The study will run until September 2026.

Researchers are investigating the effects of dynamic cycling and inclined treadmill training on balance and gait in children aged 8 to 10 years who have hearing impairments. Hearing loss in children can lead to vestibular dysfunctions, which may cause delays in gross motor development and balance difficulties, affecting their ability to participate in physical activities and social interactions. This study aims to improve understanding of how these therapies may support motor skills and overall development in this population. The study involves two groups: one group will perform dynamic cycling exercises focused on balance training, core strengthening, and proprioceptive activities for 30 minutes, three times a week, over six consecutive weeks. The other group will use an inclined treadmill set at a 10-degree angle for the same duration and frequency. Both interventions are device-based and designed to enhance balance and gait in children with hearing impairment. Participants will be assessed using the Dynamic Gait Index and the Clinical Test of Sensory Interaction and Balance (CTSIB), with each test lasting 10 to 15 minutes. Evaluations occur before and after the six-week intervention period to measure changes in balance and gait. The study uses a randomized design with single masking to monitor progress and safety throughout the participation period, which starts from September 27, 2024, and ends by December 30, 2024.

Many patients receiving platinum-based chemotherapy experience hearing problems such as ototoxicity, tinnitus, and reduced hearing acuity, which can significantly affect quality of life and treatment adherence. This study aims to compare quality of life in patients suffering from chemotherapy-induced ototoxicity who are fitted with hearing aids versus those who continue with their usual care. The study is sponsored by the Institut de Cancérologie de Lorraine and addresses the lack of consensus on managing hearing side effects from platinum treatments. Participants will be randomly assigned to one of two groups: one group will continue their usual care without hearing aids, and the other group will receive standard treatment plus hearing aids. At baseline, all patients undergo clinical and audiometric examinations and complete a quality of life survey (SF36). Follow-up visits occur at one, three, and six months after fitting, including clinical and hearing assessments and repeated quality of life questionnaires. At the six-month visit, all participants complete a satisfaction questionnaire. Throughout the study, patients continue their platinum-based chemotherapy as recommended for their cancer. Researchers will measure quality of life, hearing ability, tinnitus symptoms, and patient compliance with wearing hearing aids over six months. Clinical examinations and audiometric or tinnitus tests are performed at each scheduled visit as part of standard care. The study monitors patient outcomes to evaluate the impact of hearing aids on life quality during chemotherapy treatment.

This research aims to evaluate low-gain hearing aids programmed using either conventional audiogram-based methods or a new speech-based audiometry (SBA) approach in blast-exposed Veterans experiencing functional hearing difficulties (FHDs) despite normal or near-normal hearing. Blast injury has been linked to increased risk of auditory problems, and this study focuses on improving hearing aid fitting to better address speech recognition and listening challenges in this population. Participants will be randomly assigned to receive hearing aids programmed with either the SBA method or standard audiogram-based settings. Each group is further divided into subgroups where some use their hearing aids daily over six weeks, while others use them only for outcome testing. The study includes prescreening, preparatory visits for fitting and verification, a baseline period with assessments including fMRI and speech-in-noise tests, a five-week treatment period with weekly monitoring, and a follow-up period with repeated assessments. Throughout the study, participants will undergo a series of evaluations including audiological exams, questionnaires on hearing difficulties and cognitive function, speech recognition tests, and brain imaging during speech tasks. Hearing aid performance and usage are closely monitored with specialized equipment and data logging. Primary outcomes include changes in speech-in-noise test scores and subjective hearing aid benefit measured before and after the six-week intervention. Safety and hearing aid function are regularly checked during weekly visits, with study completion followed by transition back to routine care.