Tinnitus

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 whether brief sounds or tones played during a limited recovery sleep period after 40 hours of sleep deprivation can enhance the restorative effects of sleep and improve performance during the following awake period. This study involves healthy adults aged 18 to 39 and aims to understand how acoustic stimulation during slow-wave sleep affects alertness and cognitive functions. Participants will experience two nights of approximately four-hour recovery sleep after sleep deprivation. During these recovery sleeps, one group will receive acoustic stimulation via the Philips SmartSleep device during slow-wave sleep, while the other group will receive sham treatment without acoustic stimulation. The device is applied prior to bedtime on both recovery nights to deliver or withhold the acoustic signals. Throughout the study, participants' performance and alertness will be assessed using various tests including the Psychomotor Vigilance Task, mathematical processing tests, mood scales, and sleepiness scales over several days. Sleep and wakefulness will also be monitored via polysomnographic recordings and actigraphy. The study includes safety monitoring and adherence checks, with total participation spanning multiple days to capture effects during and after sleep deprivation and recovery.

Researchers are studying young adults aged 18 to 25 with elevated anxiety or depression symptoms and sleep disturbances. This study evaluates how acoustic stimulation during slow-wave sleep affects cognitive control and emotional responses. The trial uses devices to enhance slow-wave activity during sleep and measures behavioral, self-reported, and brain imaging outcomes to understand the impact on mood and cognition. Participants complete two overnight sessions in a sleep lab wearing a headband device that either plays sub-arousal tones during slow-wave sleep or does not. The order of these sessions is randomized. After these visits, participants use the headband device at home nightly for about two weeks, with half receiving the tones and half not, to assess longer-term effects. Throughout the study, participants undergo cognitive and emotional assessments including tasks like the AX-CPT, IAPS, and karaoke tasks, along with mood and sleep diaries. Researchers collect sleep data using polysomnography and actigraphy. Final evaluations happen after the home use period to measure changes in anxiety, depression symptoms, cognitive flexibility, and brain activity related to emotional and cognitive processes.

Researchers are studying the effects of intravenous (IV) lidocaine on tinnitus, a condition where a person hears ringing or buzzing without an external sound. This early-phase, exploratory pilot study aims to observe brain activity changes using functional MRI (fMRI) in adults with different hearing and tinnitus conditions. The study includes groups with normal hearing and no tinnitus, normal hearing with tinnitus, unilateral hearing loss with tinnitus, and bilateral hearing loss with tinnitus. The goal is to identify neural networks involved in tinnitus and assess subjective changes in tinnitus perception after lidocaine infusion. The study will enroll 40 participants divided equally among the four groups. Each participant will receive an IV lidocaine infusion at a rate of 1000mg/hour for up to 30 minutes, with a maximum total dose of 500mg. During the infusion, patients are monitored every 5 minutes for vital signs and any side effects. Brain activity will be measured using fMRI before and after the infusion. Audiograms, middle ear reflex tests, and questionnaires assessing tinnitus severity will be completed before and after the lidocaine treatment. Blood samples will be taken to measure lidocaine levels and evaluate liver and kidney function. Participants will attend screening and baseline visits involving MRI scans, hearing tests, questionnaires, blood draws, and an EKG. After the infusion visit, follow-up will be conducted via email about 30 days later to monitor any adverse events and repeat tinnitus questionnaires. The main outcome is to compare brain imaging results before and after lidocaine administration to understand tinnitus-related neural activity. Secondary outcomes include changes in tinnitus severity based on validated questionnaires. Total visit times vary from 3 to 8 hours depending on prior screening completion, and safety and subjective responses will be closely monitored throughout the study.

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 conducting the Apple Health Study to create a diverse group of participants and improve understanding of how data collected from apps and devices can relate to health. The study focuses on various aspects including mental health, sleep, exercise, hormones, metabolic health, hearing, aging, lifestyle factors, neurological conditions, general health, wellbeing, and women's health. This is an observational study aiming to use this information to help predict, detect, monitor, and manage health changes. Participants in this fully remote study will use their iPhone and the Apple Research app to share data and complete tasks. They can select the types of health and sensor data they want to share, and will answer surveys covering personal demographics, medical history, family history, and social factors. There is no treatment or drug involved, as this study observes health information collected digitally. During the study, participants will provide baseline health status information and follow-up data every six months for up to five years. They will also share demographic details, lifestyle and environment information, and family health history. The study monitors these factors over time to better understand health trends. Participation involves regular surveys and data sharing via the app, with all activities completed remotely from home.

Researchers are studying tinnitus, a condition involving ringing in the ears, to evaluate how well acupuncture works for patients using advanced brain imaging and machine learning. This study aims to build a model predicting acupuncture's clinical effects on patients with chronic subjective tinnitus by analyzing brain activity data collected through functional near-infrared spectroscopy (fNIRS). The research will involve 500 participants aged 18 to 60 who meet specific diagnostic criteria for tinnitus. Participants will receive acupuncture treatment three times a week for four weeks at specific acupoints, including TE17 (Yifeng), SI19 (Tinggong), and others. Brain imaging data will be collected from all detection channels using fNIRS before and after the acupuncture treatment. Based on their recovery status after treatment, participants will be grouped into "good prognosis" or "poor prognosis" categories. The collected data will be divided into training and test sets to develop the machine learning model. Throughout the study, researchers will assess changes in resting-state functional connectivity, hemoglobin signals, and tinnitus severity grading before and after treatment. Additional measures include the Tinnitus Handicap Inventory score and pure-tone hearing thresholds. Participants will be monitored for treatment response and safety during the 4-week acupuncture course, with data collected at baseline and post-treatment to evaluate outcomes and build predictive models.

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 evaluating a new approach to reduce tinnitus loudness and distress in adults with chronic tonal tinnitus. The study tests non-invasive electrical stimulation of the greater occipital nerve (NITESGON) combined with an attention-demanding auditory frequency discrimination training task. Conducted as a double-blind, placebo-controlled trial at Trinity College Dublin, the study involves 100 adults randomized into four groups to compare real versus sham stimulation and active versus passive listening. Participants receive eight sessions over four weeks, with two sessions each week. The interventions include real or sham NITESGON delivered via electrodes on the neck while participants either actively engage in auditory training or passively listen during a visual task. Each session lasts about 45 minutes. The study measures tinnitus loudness, functional impact, and handicap, among other auditory and physiological outcomes. Throughout the study, participants undergo assessments at baseline, after treatment, and at 28 days and 6 months post-treatment. Evaluations include tinnitus loudness scales, questionnaires, hearing tests, speech-in-noise performance, EEG recordings, heart rate, saliva biomarkers, and quality of life measures. Safety and blinding are monitored during the treatment period. The total participation spans several months with follow-up visits to track long-term effects.