Clinical Research Directory

Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss

This project aims to evaluate the clinical efficacy of Yiyuancong, an independently developed traditional Chinese medicine (TCM) formula based on the homology of medicine and food, in participants with sudden sensorineural hearing loss (SSNHL) and to elucidate its potential underlying mechanisms. This study is designed as a multicenter, randomized controlled trial (RCT), utilizing dynamic randomization for participant allocation. Due to the requirement for the experimental group to continuously administer the TCM preparation for 1-2 months, this study is conducted as an open-label (non-blinded) trial. All participants will undergo audiological evaluations at baseline, day 7 of treatment, and upon completion of the first and second treatment courses. Based on previous research regarding integrated traditional Chinese and Western medicine for SSNHL, the estimated effect size (ES) for the improvement of pure-tone thresholds compared with Western medicine alone ranges from 0.5 to 0.8. Assuming an effect size of 0.5 for the difference in pure-tone audiometry (PTA) improvement between the experimental and control groups, with a significance level (α) of 0.05 (one-tailed) and a statistical power (1-β) of 0.8, the required sample size calculated via G\*Power software is 51 per group. Accounting for a 20% dropout rate, the investigators plan to enroll 64 participants per group (total N = 128).

Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss

The HEAR-RESTORE study is an exploratory clinical research program designed to evaluate new diagnostic and regenerative approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss. Inner ear disorders can result from acoustic trauma, infections, inflammation, or other conditions that affect the cochlea, auditory nerve, or vestibular system. These conditions may lead to muffled hearing, ringing in the ears (tinnitus), balance disturbances, or reduced hearing sensitivity. The purpose of this study is to better understand how inner ear injuries develop and to evaluate potential treatments that may support hearing recovery or protect auditory function. Participants will undergo comprehensive ear and hearing evaluations including audiometry, speech recognition testing, tympanometry, and other diagnostic assessments used in audiology and otolaryngology. These tests help measure hearing thresholds, ear pressure, and auditory nerve responses. The study may also explore emerging regenerative medicine strategies aimed at restoring inner ear function. These approaches may include investigational therapies designed to promote repair of cochlear hair cells, reduce inflammation in the inner ear, or support neural recovery in the auditory pathway. Research may include evaluation of regenerative biological therapies, stem cell-based approaches, and other experimental technologies intended to support recovery of hearing or reduce symptoms such as tinnitus. Participants will be monitored over time to assess hearing outcomes, safety, and changes in auditory function. Study assessments may include repeat audiology tests, imaging studies, symptom questionnaires, and other clinical measurements used to track hearing health. The results of this research may contribute to improved diagnostic methods and potential future treatments for individuals with hearing loss or inner ear disorders.

Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant

The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant. The main questions it aims to answer are: * Does the Acclaim CI device help participants hear words better compared to before the implants? * What medical problems do participants have after the Acclaim CI device was implanted? Participants will: * Have the Acclaim CI implanted; and * Visit the clinical site for checkups and tests at 1-Month, 3-Months, 6-Months, and at 1-year and 2-years after the device has been turned on.

First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant

Rinri Therapeutics is conducting a clinical trial of a new cell therapy called Rincell-1. Rincell-1 is being developed to treat adults with neural hearing loss, either age related hearing loss or auditory neuropathy, who also meet criteria for a cochlear implant. The goals of this study are: * To learn about the safety profile of Rincell-1, the procedure used to inject it and the medications given to promote the growth of the cells * To evaluate how well Rincell-1 works by measuring changes in the function of auditory neurons. * To understand if Rincell-1 can be easily and successfully given at the same time as cochlear implant surgery Participants will be randomly assigned to one of two groups: one group that receives a standard care cochlear implant, and the other that will receive an injection of Rincell-1 at the same time as their standard care cochlear implant. Researchers will compare the safety of Rincell-1 in combination with a cochlear implant to a cochlear implant on its own. Participants will take part in the trial for 52 weeks after CI surgery. During that time, they will have regular follow-ups and will take daily measurements at home of their hearing health.

Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness

In patients with symmetric hearing loss who meet traditional cochlear implant candidacy criteria yet demonstrate pre-operative unilateral vestibular weakness, the choice of which ear to implant may impact their post-operative vestibular course. The investigators aim to implement both objective videonystagmography metrics as well as subjective patient-reported outcome measures to assess whether selecting laterality for cochlear implantation as it relates to unilateral vestibular loss has a measurable impact on patients' post-operative vestibular function. In pursuing cochlear implantation on the ear that demonstrates worse vestibular function, the investigators hypothesize improved vestibular function in comparison to operating on the unaffected side. The randomized control pilot study plans to allocate 10 subjects to a treatment group that involves cochlear implantation on the ipsilateral side of vestibular hypofunction and a control group that will undergo implantation on the contralateral side. The investigators plan to compare scores derived from the Dizziness Handicap Inventory completed at pre-operative evaluation and at two subsequent post-operative visits between control and treatment groups as primary outcome. The investigators also plan to determine if there is a significant difference in measures derived from caloric vestibular testing pre- and post-operatively as well as between control and treatment groups.

Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing

The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised data-driven protocol for early hearing rehabilitation. The main hypothesis is that, compared with standard care, the data-driven rehabilitation will likely have broader benefits manifested in three key areas: hearing, cognition, and quality of life and psychosocial outcomes. Participants will be randomized 1:1 to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation). The primary objective of this study is to investigate the effect of an optimized data-driven hearing rehabilitation protocol versus standard care protocol on change in speech perception in noise (SPIN) in older adults with mild to moderately severe sensorineural HI and without dementia.

Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome

The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS). The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile. The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases? Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL). Participants will undergo the following tests: * Ear examinations * Hearing tests * Balance tests * Blood tests * MRI scans * CBCT (cone-beam computed tomography) scans

Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial

The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy. Cisplatin is a highly effective chemotherapeutic agent but often leads to permanent hearing loss (ototoxicity) as a significant side effect. This study investigates whether the administration of NAC as an otoprotective agent can reduce or prevent the decline in hearing sensitivity, particularly at extended high frequencies, as measured by audiometry and distortion product otoacoustic emissions (DPOAE).

Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants

This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use. The main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care. This study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.

Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss

This research is being done to determine whether a test that measures a "Visual Evoked Potential" can be used in a new way for individuals that have hearing loss. This test measures the participant's brain's response (so called "brain waves") to specific visual images. This study will help the investigators determine whether this test could be used to improve treatments for patients with hearing loss. The "Visual Evoked Potential" measurement test is already used in the investigator's Neurology clinic at Dartmouth Hitchcock Medical Center for various conditions to measure "early" brain responses that occur in the first 1-2 seconds after a new cue. Our research aims to explore your brain's response just after that early 1-2 second period by looking at a specific response called the "P300". The P300 wave is a brain response to new or different images or sounds. A visual evoked P300 has not been studied in individuals with hearing loss. The investigators will compare the results of this test to standard auditory tests, tests of cognitive function, and cochlear implant patient outcomes to explore how these factors can predict successful use of a hearing aid or cochlear implant.

Hearing Preservation in Cochlear Implantation Surgery

In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a \*straight\* lateral wall lying electrode array (LW), or a \*pre-curved\* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires and vestibular and postural assessments.

Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.

Sensorineural Hearing Loss Imprint

this study will investigate the consequences of sensorineural hearing loss on manual dexterity and coordination skills in Children.

Long-Term Outcomes of Children With Congenital CMV in New York State

PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms. In particular, our study will provide new information about many facets of congenital CMV, including: * Developmental, hearing, neurologic, and vision outcomes * The spectrum and timing of symptoms * The impact congenital CMV has on the baby and its family * How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications. Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment. Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.

Cochlear Implanted Listening Effort and Hearing Attention

Cochlear implant users perceive mainly sound amplitude modulation cues. Processing of these amplitude modulations can be subject to interferences, so that the perception of a modulation in a target sound can be impaired by a superimposed sound if this sound contains a similar modulation. Such phenomenon, which is observed both in subjects with normal-hearing and in cochlear-implant users, could be explained by difficulties to direct attention to relevant information in complex sound signals. Selective auditory attention also plays a crucial role in speech comprehension in cocktail-party situations where the speech of multiple talkers get mixed at the ear of a listener. Cochlear implant users typically struggle in these cocktail-party situations and report intense listening effort. The present clinical trial aims at evaluating the contribution of selective auditory attention for sound modulations to the listening effort of patients with cochlear implants and of healthy volunteers with normal-hearing during speech perception under cocktail-party-like conditions. Selective auditory attention abilities of patients and controls will be assessed using a psychoacoustical test whereby their ability to detect a target sound amplitude modulation will be measured both in the absence and in the presence of an interfering (i.e. distracting) amplitude modulation occurring in a distant spectral region from that of the target. The effect of this distractor's presence on modulation detection performance will serve as a behavioural index of the subject's auditory attention capacities. The attentional capacity index will then be tested as a predicting factor for the listening effort of the subject during a speech-in-noise consonant identification task. Listening effort will be measured from the pupil dilation response to the presented speech units (pseudowords). This study will enhance our understanding of cochlear implant user's perception and listening effort and will serve as a basis for prognostic tests of listening effort and of implantation success for cochlear implant candidates, based on a simple measurement of auditory attentional abilities.

Effects of Clear Speech on Listening Effort and Memory in Sentence Processing

Sensorineural hearing loss (SNHL) is among the most prevalent chronic conditions in aging and has a profoundly negative effect on speech comprehension, leading to increased social isolation, reduced quality of life, and increased risk for the development of dementia in older adulthood. Typical audiological tests and interventions, which focus on measuring and restoring audibility, do not explain the full range of cognitive difficulties that adults with hearing loss experience in speech comprehension. For example, adults with SNHL have to work disproportionally harder to decode acoustically degraded speech. That additional effort is thought to diminish shared executive and attentional resources for higher-level language processes, impacting subsequent comprehension and memory, even when speech is completely intelligible. This phenomenon has been referred to as listening effort (LE). There is a growing understanding that these cognitive factors are a critical and often "hidden effect" of hearing loss. At the same time, the effects of LE on the neural mechanisms of language processing and memory in SNHL are currently not well understood. In order to develop evidence-based assessments and interventions to improve comprehension and memory in SNHL, it is critical that the cognitive and neural mechanisms of LE and its consequences for speech comprehension are elucidated. In this project, the investigators adopt a multi-method approach, combining methods from clinical audiology, psycholinguistics, and cognitive neuroscience to address this gap of knowledge. Specifically, the investigators adopt a novel and innovative method of co-registering pupillometry (a reliable physiological measure of LE) and language-related event-related brain potential (ERP) measures during real-time speech processing to characterize the effects of clear speech (i.e., a listener-oriented speaking style that is spontaneously adopted to improve intelligibility when speakers are aware of a perception difficulty on behalf of the listener) on high-level language processes (e.g., semantic retrieval, syntactic integration) and subsequent speech memory in older adults with SNHL. This innovative work addresses a time-sensitive gap in the literature regarding the identification of objective and reliable markers of specific neurocognitive processes impacted by speech clarity and LE in age-related SNHL.

Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

Sudden deafness is a common emergency in otorhinolaryngology. As the etiology and mechanism of sudden deafness remains unknown, there is no specific treatment. Therefore, to explore new treatments for sudden deafness is a urgent and challenging problem. Extracellular vesicles therapy has been proved to be effective for several diseases. From our previous study, extracellular vesicles from mesenchymal stem cell can effectively improve noise-induced sensorineural deafness in mice. While mesenchymal stem cell therapy faces immune rejection in clinical use, the investigators use autologous blood monocyte vesicles to avoid immune rejection and guarantee patients' safety. In this interventional study, the investigators aimed to study the clinical effects and adverse reactions of autologous blood monocyte vesicle therapy in the treatment of sudden deafness. A total of 30 patients with severe or worse sudden deafness will enroll in this study and randomly assigned to 3 group, which are control group (Intratympanic glucocorticoid injection), lower-dose apoVs group (lower dose of Intratympanic monocyte vesicles injection) and higher-dose apoVs group (higher dose of Intratympanic monocyte vesicles injection). This study will further promote new treatment for sudden deafness and improve the quality of life and prognosis of patients with sudden deafness, especially those with severe or extremely severe deafness.

Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.

Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning

The goal of this study is to investigate the role of social factors on speech learning, including production and perception, in infants ranging in age from \~7-18 months. Infants have either typical hearing or sensorineural hearing loss. The main prediction of the study is that social reinforcement will engender improvements in vocal learning above and beyond gains in hearing in infants with hearing loss. As part of this study: * The parent and infant engage in a free play session in the playroom while the investigator cues the parent to say simple nonsense words; * Infants hear playback of the same words during a second phase.

Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss

DTI and auditory tractography can be incorporated into the diagnostic toolkit for patients who are scheduled to undergo cochlear implantation and whose standard assessments have been unable to determine the functional integrity of the auditory pathway. These techniques aid in decision-making processes regarding potential outcomes, determining the optimal side for implantation, providing counseling regarding the possibility of limited benefits from surgery, and considering alternative forms of rehabilitation. The investigators including patients with varying degrees of hearing loss, as well as patients with normal radiological findings who are scheduled for cochlear implantation. The ultimate goal is to create a comprehensive map across the entire hearing spectrum and validate the findings of this study..

Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools

Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range of TIM profiles within the implanted population, certain profiles suggesting the growth of the fibrosis tissue in cochlea

Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss

Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation. Although the mechanisms involved in the residual audition loss remain unknown, animal experiments suggest the role of inflammatory or immune reaction in the cochlea. The goal of this project is to search in the perilymph (a fluid which fills the scala vestibuli and scala tympani of the cochlea) some predictive biomarkers of the residual hearing loss using modern proteomics and immunological techniques. A parallel search for blood biomarkers of post-implantation residual hearing loss and for molecular and cellular evidences of immune response to cochlear implantation will be performed. The study will recruit 50 subjects-candidates for cochlear implantation surgery; 30 normally hearing individuals eligible for other types of otological interventions will form a control group. For all the participants blood samples will be collected and preserved. In addition, the perilymph sampling will be performed during cochlear implantation surgery. This project relies on the calculation that from 50 patients post-cochlear implantation, 15 patients will form a group with maintained residual hearing and 15 will display delayed hearing loss. For these 30 subjects together with the control group the blood biomarkers search will be performed. For the group of implanted patients, the follow-up will last for 12 months with 6 visits in total : * the inclusion visit V0 during which the study will be presented and the consent form will be signed * the surgery visit V1 with blood sample and perilymph collection * the activation visit V2, 1 month ± 1 week after V1, visit V3 3 months ± 7 days after V1, V4 6 months ± 7 days after V1, V5 12 months ± 1 month after V1. During each of this visit blood sampling will be performed. For the control group, the follow up will be 6 months long with 4 visits in total arranged during the routine follow-up appointments: * the inclusion visit V0 during which the study will be presented and the consent form will be signed * the surgery visit V1, the 1 month visit V2 and the 6 months visit V3 during which the blood sampling will be performed.