[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"deafness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:deafness":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,46,69,99,135,158,189,209,236,257,279,303,326,356,382,408],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100617674","evaluation-of-the-effectiveness-of-a-rehabilitation-program-for-hearing-and-communication-disorders-in-elderly-people-in-nursing-homes-100617674",false,"NCT07321691","Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes.","Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes: a Single Case Experimental Design (N of 1 Trials Study)","HEAR2SHARE","Inclusion Criteria:\n\n* residents in nursing homes with hearing impairment (HHIE-S (Hearing Handicap Inventory for the Elderly Screening and pure tone audiometry)\n* with an MMS (Mini Mental State) score\\> 15\n* with a GIR Group ≥ à 3 affiliated to a social security scheme\n* French speaking\n\nExclusion Criteria:\n\n* wearing any type of hearing aid at the time of inclusion\n\n  * having followed a similar training program\n  * Subjects under juridical protections or tutelage measure\n  * unable to answer questions and participate in group activities\n  * with associated life-threatening pathologies and\u002For a life expectancy in EHPAD of less than 6 months","ALL","60 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","In France, 64% of residents in nursing homes have moderate to severe hearing loss and only 12% are treated with hearing aids. Yet the extra-auditory consequences of presbycusis are numerous: general fatigue, isolation, anxiety and depression. France counted 620 000 nursing home beds in 2020 and this number increases each year by an average of 2% (DREES (Department of Research, Studies, Evaluation and Statistics), France, 2019). Only few studies have focused on hearing disorders in this population, given the importance of their communication difficulties (Solheim J et al., 2016, Kimball A et al., 2017 ). The population in nursing homes is for 80% over 80 years old (DREES (Department of Research, Studies, Evaluation and Statistics) survey, France, 2014). This same survey looked at the proportion of people with functional hearing limitations and their severity depending on where they live. The highest rates were found among people living in institutions (regardless of the degree of functional hearing limitations), with 42% of people living in nursing homes and senior residences who have hearing functional limitations against 15.9 % of those living at home The present study is interested in the management of hearing and communication disorders in nursing homes residents by setting up a program for the rehabilitation of these disorders, based on the use of a simple hearing device by the nursing home staff.",[27],"Deafness",[29,30,31,32],"deafness","rehabilitation","nursing homes","elderly subject","NOT_YET_RECRUITING","2026-05-18",{"date":36,"type":37},"2026-05-19","ACTUAL",{"date":39,"type":21},"2026-09",{"date":41,"type":21},"2028-02",{"name":43,"class":44},"University Hospital, Toulouse","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100589915","improving-clinical-efficiency-by-reducing-scheduled-follow-ups-using-cochlear-americas-population-mean-mapping-strategy-100589915","NCT06960616","Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy","Inclusion Criteria:\n\n* Postlingually deafened\n* Adults (18+)\n* New cochlear implant recipients with Cochlear Americas devices; identified prior to activation\n* Able to perform follow-up testing tasks (repeating words\u002Fsentences, indicating they heard a sound stimulus, completing questionnaires)\n* English speakers\n\nExclusion Criteria:\n\n* Patients who select other cochlear implant manufactured devices\n* Pre-lingually deafened\n* Multiple disabilities\n* Unable to perform follow-up testing tasks (repeating words\u002Fsentences, indicating they heard a sound stimulus, completing questionnaires)\n* Non-English speakers\n* Children under the age of 18","18 Years","85 Years",{"count":55,"type":21},48,[24],"The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.",[27,59],"Cochlear Hearing Loss","RECRUITING",{"date":62,"type":37},"2026-05-20",{"date":64,"type":37},"2024-02-27",{"date":66,"type":21},"2027-02-26",{"name":68,"class":44},"Massachusetts Eye and Ear Infirmary",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100490774","collection-of-clinical-data-and-specimens-for-research-in-hearing-balance-taste-smell-voice-speech-and-language-disorders-100490774","NCT05670496","Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Patients must be age 2 years or older if procedures or treatment are required.\n* Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance, taste, smell, voice, speech, language, and other ENT disorder.\n* An NIDCD clinical investigator and PI determines it is in the interest of the patient\u002Findividual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD\u002FNIH\n* Patient or their Legally Authorized Representative is able to provide informed consent. The consent form will be signed by parents or guardians of patients under the age of 18.\n* A subset of enrolled participants with known or suspected PIEZO2-related sensory dysfunction may be asked to participate in the remote taste and oral somatosensory testing procedures. Participation in this component is optional and not required for enrollment or continued participation in the parent protocol.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Candidates who do not meet the inclusion criteria.\n* Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care\n\nParticipants without known or suspected PIEZO2-related sensory dysfunction will not be asked to complete the sensory testing component. Additional exclusion criteria for taste testing only procedures include:\n\n* Active oral sores, open cuts, or significant oral pain\n* Recent oral surgery or dental procedures within the past 7 days\n* Known allergy or hypersensitivity to tannins or polyphenols\n* Acute upper respiratory infection or conditions that may interfere with taste perception","2 Years","99 Years",{"count":78,"type":21},600,"OBSERVATIONAL","Background:\n\nPeople with hearing, balance, and taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness and Other Communication Disorders (NIDCD). Some of these people may benefit from enrolling in the NIDCD intramural research program to receive their care. Enrolling will also allow investigators to collect participants clinical data and specimens for future research.\n\nObjective:\n\nThis natural history study has 2 goals: (1) to collect data and specimens that may be used for research; and (2) to evaluate participants who may be candidates for other research studies.\n\nEligibility:\n\nPeople aged 2 years or older with a hearing, balance, and communication disorder. Those at risk or who are suspected of having such a disorder are also eligible.\n\nDesign:\n\nParticipants will be screened. Their medical records will be reviewed.\n\nParticipants will agree to have their medical data used for research. Specimens such as blood or other tissue samples may also be used for research. All data and specimens will be collected during their routine care visits.\n\nAll tests done will be the normal care for each participant s condition. No tests will be done solely for research.\n\nSome of these tests may require blood or tissue samples. Some may use special tools to test hearing and balance. Some may test heart or lung function. These tests may also include different types of imaging scans.\n\nAll tests will be explained. Participants may ask questions at any time.\n\nParticipants may remain in this study for up to 2 years. If they need further care, they may sign a new consent.\n\n...",[82,27],"Hearing Loss",[27,84,85,86,87,88],"Hearing","Speech","Vestibular","Audiology","Natural History","2026-04-25",{"date":91,"type":37},"2026-04-28",{"date":93,"type":37},"2023-03-08",{"date":95,"type":21},"2032-12-01",{"name":97,"class":98},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100501383","bears-training-package-to-maximise-hearing-abilities-in-older-children-and-teenagers-with-bilateral-cochlear-implants-100501383","NCT05808543","BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants","A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants","BEARS","Inclusion Criteria:\n\n1. Participant is a simultaneous or sequential bilateral cochlear implant user\\*, who either has:\n\n   1. Congenital severe\u002Fprofound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.\n   2. Progressive or acquired severe\u002Fprofound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) \\*(a bilateral CI user is defined as a patient who uses both cochlear implant processors for a minimum of 6-hours per day over a month)\n2. Participant has stable programmes (defined as no longer using progressive programmes to work through).\n3. Participant has had at least two usual care checks\u002Fclinical appointments with stable aided levels (+\u002F- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.\n4. Participant is aged 8-16 years, inclusive.\n\nExclusion Criteria:\n\n1. Participant (or parent\u002Flegal representative) does not speak\u002Funderstand English sufficiently to undertake assessments.\n2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.\n3. Participant has a comorbid condition impacting ability to participate in the intervention and\u002For outcome assessment.\n4. Participant has an audiological profile impacting ability to participate in the intervention and\u002For outcome assessments.\n5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.\n6. Participant is currently or anticipated to receive treatment and\u002For intervention that may affect hearing outcomes or adapt implant settings\u002Fprogramming.\n7. Participant is refusing to consent to trial activities\u002Fprotocol.\n8. Participant is awaiting reimplantation following device failure or infection.\n9. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month).\n10. Participant is a fulltime boarder at a boarding school\n11. Participant has unresolvable issues found in device checks that render one of the implants unusable.\n12. Participant is a female that is pregnant.\n13. Participant has a diagnosis of epilepsy or history of seizures of any kind.","8 Years","16 Years",{"count":110,"type":21},272,[24],"The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants.\n\nThe participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.",[114,82,27,115],"Hearing Loss, Sensorineural","Hearing Impaired Children and Adolescents",[117,118,119,120,121,122,123,124],"Cochlear Implant","Virtual Reality","Children","Teenagers","Deaf","Bilateral","Training","Rehabilitation","2026-03-26",{"date":127,"type":37},"2026-04-01",{"date":129,"type":37},"2023-07-27",{"date":131,"type":21},"2026-10-31",{"name":133,"class":44},"Guy's and St Thomas' NHS Foundation Trust",13,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":17,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":45},"100454881","novel-coding-strategies-for-children-with-cochlear-implants-100454881","NCT05203302","Novel Coding Strategies for Children With Cochlear Implants","Inclusion Criteria:\n\n* Be 7 years of age or older and pre-lingually implanted with a cochlear implant (before the age of 2 years), have aided residual hearing, or have normal hearing.\n* Be ages 18 or older and post-lingually implanted or have normal hearing.\n* Be ages 18-35 and pre-lingually implanted.\n\nExclusion Criteria:\n\n* Any child implanted post-lingually",true,"6 Years","80 Years",{"count":145,"type":21},190,[24],"The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory system. Information from individuals with and without cochlear implants will be compared.",[27],"2026-03-02",{"date":151,"type":37},"2026-03-04",{"date":153,"type":37},"2018-07-12",{"date":155,"type":21},"2027-01-01",{"name":157,"class":44},"NYU Langone Health",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":45},"100622180","cochlear-implant-recipients-comprehensive-longitudinal-evaluation-100622180","NCT07380269","Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation","Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages","CIRCLE","Inclusion Criteria:\n\n* Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.\n* No restrictions on age or gender.\n* Native language is Mandarin Chinese.\n* The subject and\u002For their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.\n* Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.\n* The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.\n\nExclusion Criteria:\n\n* Presence of other severe diseases unsuitable for cochlear implantation surgery.\n* Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.\n* Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.\n* Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.\n* Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical study.",{"count":167,"type":21},300,"This study aims to assess hearing and speech perception, as well as quality of life, in deaf patients of all ages before and after cochlear implantation, and to explore differences across age groups and treatment subtypes, thereby providing evidence for personalized hearing and speech rehabilitation.",[82,114,27,170,171],"Cochlear Implantation","Speech Perception",[117,173,174,175,176,177,178,179],"Pediatric Cochlear Implantation","Adult Cochlear Implantation","Auditory Rehabilitation","Speech Recognition","Quality of Life","Cognitive Function","Observational Cohort","2026-01-27",{"date":182,"type":37},"2026-02-02",{"date":184,"type":37},"2025-08-22",{"date":186,"type":21},"2030-09",{"name":188,"class":44},"Eye & ENT Hospital of Fudan University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":45},"100501512","investigating-auditory-processing-in-the-users-of-auditory-brainstem-and-cochlear-implants-100501512","NCT05810220","Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants","Inclusion Criteria:\n\n* Hearing impaired adult and or child (above 2 years old) who uses ABIs or cochlear implants.\n* No diagnosis of any other communicative or cognitive disorder other than hearing impairment. The individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments.\n* Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.\n\nExclusion Criteria:\n\n* Diagnosed cognitive or communicative disorders (other than hearing impairment)\n* Severe neurological disorders\n* No useable electrodes in their implants","90 Years",{"count":197,"type":21},200,[24],"This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.",[27],"2025-12-23",{"date":203,"type":37},"2025-12-30",{"date":205,"type":37},"2018-12-02",{"date":207,"type":21},"2026-12",{"name":157,"class":44},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":218,"studyType":79,"phases":4,"briefSummary":219,"conditions":220,"keywords":226,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":45},"100273617","wolfram-syndrome-and-wfs1-related-disorders-international-registry-and-clinical-study-100273617","NCT02841553","Wolfram Syndrome and WFS1-related Disorders International Registry and Clinical Study","Any patient worldwide with a diagnosis of Wolfram syndrome and with access to the Internet can be enrolled in the Registry. Since the disease usually manifests in the first decade of life and tends to have an inevitably progressive course, participation of minors is important for establishing the natural course of the disease.\n\nInclusion Criteria:\n\nMajor Criteria\n\n* Diabetes mellitus \\\u003C16 yrs\n* Optic atrophy \\\u003C16 yrs\n\nMinor Criteria\n\n* Diabetes insipidus\n* Diabetes mellitus \\>16yrs\n* Optic atrophy \\>16 yrs\n* Sensorineural deafness\n* Neurological signs (ataxia, epilepsy, cognitive impairment)\n* Renal tract abnormalities (structural or functional)\n* 1 loss of function mutation in WFS1\u002FCISD2 AND\u002FOR family history of Wolfram syndrome\n\nMinimum Required\n\n* 2 major OR\n* 1 major plus 2 minor criteria OR\n* 2 pathological WFS1 or CISD2 mutations are identified\n\nOther variable suggestive evidence\n\n* Hypogonadism (males)\n* An absence of type 1 diabetes auto-antibodies\n* Bilateral cataracts\n* Psychiatric disorder\n* Gastrointestinal\n\nExclusion Criteria:\n\nInability of a patient and\u002For a guardian to obtain help with translation and thus, inability to understand questionnaire.\n\nParent, Sibs, and Spouses:\n\n\\- Parents, sibs, and spouses that are unaffected will be recruited as controls. Inclusion criterion is having the unaffected status and exclusion criterion is if the person cannot understand the Informed Consent Document.","0 Years",{"count":217,"type":21},5000,"20 Years","In this study, the investigators hypothesize that studying monogenic variants with strong effect associated with severe insulin deficiency of Wolfram syndrome will provide important insights into the more complex type 1 and type 2 diabetes mellitus.\n\nAim 1. Establish and maintain a registry of patients with Wolfram syndrome. An Internet based registry will be employed to enroll participants with the clinical diagnosis of Wolfram syndrome (insulin dependent DM and bilateral OA). Clinical information regarding age of diagnosis and progression of the disease will be collated and analyzed to better define its natural history, along with potential metabolic phenotypes such as glucose intolerance of heterozygous parents and unaffected sibs.\n\nIf not already completed, blood for WFS1 sequence analysis will be obtained on the participants (parents and sibs also for control purposes) and sent to a CLIA certified lab to define the mutation. This information will benefit patient families and referring physicians by providing a genetic diagnosis and where indicated. The Wolfram Syndrome Registry will foster international collaborations to more efficiently and systematically collect Wolfram syndrome patients and their clinical and experimental data.",[221,222,223,27,224,225],"Wolfram Syndrome","Diabetes Mellitus","Optic Nerve Atrophy","Diabetes Insipidus","Ataxia",[227],"Endoplasmic Reticulum Stress","2025-12-19",{"date":201,"type":37},{"date":231,"type":4},"2011-07",{"date":233,"type":21},"2027-04",{"name":235,"class":44},"Washington University School of Medicine",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":141,"sex":17,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100505883","perceptual-consequences-of-cochlear-implant-electrode-neuron-interfaces-100505883","NCT05867173","Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces","Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners","Inclusion Criteria:\n\nResearch Subjects with a Cochlear Implant ADULTS Inclusion Criteria\n\n* Adult at least 18 years old\n* Native speakers of American English\n* Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL\n\nCHILDREN Inclusion Criteria\n\n* Children at least 3 months old\n* Native speakers of American English\n* Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL\n\n  * For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.\n\nExclusion Criteria:\n\nExclusion for all Cochlear Implant Subjects:\n\n* Inability to provide informed consent\n* Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device\n* Unable to carry out the study protocol or tasks required in the study\n\nExclusion for all Normal Hearing Subjects:\n\n* Inability to provide informed consent\n* Hearing loss, or significant history of hearing related issues\n* Unable to carry out the study protocol or tasks required in the study","3 Months",{"count":197,"type":21},[24],"Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.",[27],"2025-11-25",{"date":250,"type":37},"2025-11-26",{"date":252,"type":37},"2022-09-16",{"date":254,"type":21},"2027-03-31",{"name":68,"class":44},2,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":4},"100602012","benefit-of-connected-care-for-cochlear-implant-management-100602012","NCT07117968","Benefit of Connected Care for Cochlear Implant Management","Evaluating the Benefit of Integrating Connected Care to Reshape the Cochlear Implant Care Pathway: a Multicenter Randomized Non-inferiority Study","Connect IC","Inclusion Criteria:\n\n* Adult patients (aged 18 or over) eligible for a cochlear implant in primary implantation according to French National Authority for Health indications\n* Patients suffering from severe to profound bilateral deafness with discrimination less than or equal to 50% on voice audiometry tests using the Fournier list (or equivalent).\n* Patients affiliated to the public health insurance body\n* Patients who benefit from a Cochlear® system with a processor compatible with Remote Care tools\n* Patients using a smartphone compatible with the Nucleus Smart application.\n* Patients who have given their written informed consent to the study\n* French-speaking patients\n\nExclusion Criteria:\n\n* Patients already implanted and candidates for implantation of the other ear (bilateralization), or previously implanted (re-implantation).\n* Patients with concomitant illnesses that are incompatible with the use of remote monitoring,\n* Pregnant women\n* Patients suffering from unilateral deafness with incapacitating tinnitus\n* Persons under legal protection (guardianship, curators).\n* Subjects taking part in other interventional research with an exclusion period still in progress at the time of inclusion.",{"count":266,"type":21},130,[24],"Some 30 hospitals in France are accredited to manage cochlear implant (CI) activity, which represents around 1,800 new patients implanted per year and an estimated active file of over 20,000 patients.\n\nThe current patient pathway meets the requirements described in 2009 for this activity. Today, however, it is inflexible, not scalable, and presents major constraints for both patients and the healthcare professionals in charge of them. In the first year post-implantation, a patient visits his or her center on average 9 times for routine follow-up. The growing demand for patients to be implanted and the need to continue monitoring patients who have already been implanted are putting a strain on the centers responsible for this activity, leading to a deterioration in the management of this condition. We need to propose a new care pathway that meets current needs, improves patient service and optimizes the workload of our teams in order to manage their entire implant cohort.\n\nThis project focuses on two areas in order to optimize the implant patient's care pathway. The first is to integrate telemonitoring into the follow-up process. Telemonitoring has already proved its worth in many therapeutic fields, and could clearly meet the needs of all those involved: Reduced time constraints, optimized on-site visits, flexibility in management, fewer people lost to follow-up... The second axis consists in optimizing the implant system activation stage, a cumbersome and complex step, by favoring early activation based on objective patient data collected intraoperatively. Reducing the variability of activation leads to earlier stabilization of settings, without compromising hearing performance.\n\nThese two approaches are currently used in some centers, but not in combination, and have been adopted routinely in some countries. The expected benefits are therefore well known, but this project has a key role to play in demonstrating the feasibility and medico-economic benefits of our French model.\n\nThis project will therefore jointly optimize early activation, made possible by objective intraoperative measurements, and patient management by integrating telemonitoring into the adult CI pathway to improve efficiency.\n\nThe aim of this project is to evaluate, in the first year of post-CI follow-up, the benefits of this new, adapted care pathway, both in terms of the organization of care and the patient's quality of life and performance.\n\nThe main hypothesis is that a new care pathway that integrates early activation and remote monitoring will enable the center to provide more flexible and adapted patient follow-up to optimize management, and thus improve quality of life without any deterioration in clinical effectiveness (hearing performance). The investigators aim to demonstrate the clinical non-inferiority of performance in noise (DTT Test) assessed at 12 months in patients benefiting from the new care pathway vs. current standard follow-up, while improving their quality of life, in a multicenter randomized controlled trial.",[27],"2025-09-04",{"date":272,"type":37},"2025-09-11",{"date":274,"type":21},"2025-10-01",{"date":276,"type":21},"2029-10-01",{"name":278,"class":44},"Hospices Civils de Lyon",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":45},"100522925","early-detection-of-deafness-in-a-memory-center-100522925","NCT06088953","EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER","DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS","CogAudio","Inclusion Criteria:\n\n* Patient with mild to moderate cognitive impairment, with an MMSE score ≥15\u002F30\n* Patient mastering the French language\n* Patient who has given written consent to participate in the trial\n* Socially insured patient\n* Patient willing to comply with all study procedures and duration\n* Patient accompanied by a study partner\n\nExclusion Criteria:\n\n* Medical history of diagnosed deafness, fitted or not\n* History of progressive otological pathology or presence of tympanic obstruction (\\>1\u002F3 of the surface of the eardrum)\n* History of unstabilized psychiatric pathology\n* Major visual impairment (Age-Related Macular Degeneration AMD...)\n* Established diagnosis of major language disorders (Primary Progressive Aphasia APP...)\n* Major under legal protection measure","50 Years",{"count":197,"type":21},[24],"Age-related hearing loss (ARHL), like neurodegenerative diseases, appears insidiously with age. As major public health issues, they are nonetheless under-diagnosed because the presence of one can hinder the objectification of the other.\n\nThe CogAudio project aims to detect early and in an ambulatory mode in a memory centre a speech perception disorder in noise thanks to the VRB test in patients weakened by cognitive disorders.",[292,27],"Cognitive Disorder",[292,27],"2025-08-19",{"date":296,"type":37},"2025-08-20",{"date":298,"type":37},"2025-05-27",{"date":300,"type":21},"2027-08-27",{"name":302,"class":44},"University Hospital, Lille",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":310,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":45},"100593923","a-clinical-trial-of-the-safety-and-efficacy-of-tj0113-capsules-in-the-treatment-of-patients-with-age-related-hearing-loss-100593923","NCT07012746","A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss","A Randomized, Double-Blind, Placebo-Parallel-Controlled Clinical Trial to Explore the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss","Inclusion Criteria:\n\n1. The subjects voluntarily participate in the clinical trial, sign the informed consent form, understand and follow the protocol, and fully understand the test content, process and possible adverse reactions.\n2. Age between 65 and 80 years (including the critical value)\n3. A diagnosis of symmetrical sensorineural deafness (SNHL) with a history of\\> 3 months (binaural threshold difference in mean PTA frequency \\\u003C15 dB HL), the PTA level should be between moderate (\\> 35dB) and severe (\\\u003C80dB) hearing loss\n4. Hearing aids have not been used, or otherwise, it should be used regularly for more than 3 years and stopped for 3 months before enrollment.\n5. Subjects and their partners had no birth plan, sperm or egg donation plans from the screening period until within 6 months after the end of the trial and would voluntarily take effective contraception (e. g. abstinence, condoms, etc.). Male subjects should agree to avoid sperm donation within 6 months from the start of administration until cessation of study treatment. Female subjects should be menopausal (over 24 months).\n\nExclusion Criteria:\n\n1. The presence of implants in the study ear (such as cochlear implant, artificial hearing bone, etc.);\n2. Suffering from acute otitis media or other ear infection within the previous 3 months or previous chronic suppurative otitis media or tympanic membrane perforation, or with conductive deafness, previous history of ear trauma or surgery, combined middle ear or inner ear malformation, otosclerosis, Meniere's disease, sudden deafness and no recovery of hearing, all of which will impact results explained.\n3. Patients with sensorineural deafness caused by non-aging factors (e. g., hereditary deafness, congenital deafness, drug-induced deafness, noise deafness, neurosyphilis, severe retrocochlear lesions or organic lesions), and unilateral deafness\n4. Occupation that is sensitive to sound: musician, conductor, music teacher, etc.\n5. Use headphones at high volume or frequent exposure to noise in previous work or life;\n6. History of alcohol or drug dependence \u002F drug abuse in the last 1 year;\n7. Positive pregnancy test at screening or at the baseline visit, pregnant, lactating, or planned to become pregnant during the trial\n\n7.Failure to swallow oral medication, or, according to the investigator, any conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or that may pose a hazard to the subjects participating in this trial; 9.People who currently taking drugs that can improve symptoms such as dementia and depression 10.Subjects with a severe or unstable systemic disease, such as serious congenital disease, blood disease, endocrine disease, nerve or nervous system disease, end-stage disease, head and neck tumor radiotherapy and chemotherapy history, major surgical treatment, psychological disorders (severe insomnia, severe depression, severe anxiety, etc. diagnosed within the previous 90 days ) or history and clinical significance of abnormal baseline laboratory values, such as hepatic insufficiency (alanine transaminase (ALT) and \u002F or alanine transaminase (AST) is 2 times above the upper limit of the reference range, or renal insufficiency (creatinine clearance Ccr \\\u003C30 mL\u002Fmin), or history of malignant tumors and the detection results of tumor markers during the screening period have clinical significance, or unsuitable participants, as judged by the investigator; 11.Subjects suffering from any one of the following heart diseases: a. having uncontrolled or serious cardiovascular and cerebrovascular disease, including the development of grade II ( New York Heart Association, NYHA) or above congestive heart failure, unstable angina, acute myocardial infarction within 6 months before the first drug administration, or cardiac arrhythmias requiring treatment at screening; With b. hypertension (systolic pressure≥ 160mmHg and \u002F or diastolic v≥ 100mmHg), and after the combination of two or more antihypertensive drugs can not be reduced to the normal range; or c.with a history of clinically significant ECG abnormalities, the QRS time was\\> 120ms, Long QT syndrome: QTc interval\\> 450ms in male or QTc interval\\> 470ms in female.\n\n12.Participated in a clinical study involving the administration, device, or surgery of the study drug (new chemical entity) within 90 days or 5 half-lives (whichever is longer) 13.Patients with a previous history of hepatitis B, or any of the following indicators are positive at screening: hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.\n\n14.The subject is not fit to participate in the study if the investigator considers. Or the subject could not participate in the trial for his own reasons, or the behavior subject may interfere with treatment, study or interpretation of results (e. g., previous treatment with high-dose aminoglycosides).","65 Years","75 Years",{"count":313,"type":21},60,[24],"The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.",[317,27],"Age Related Hearing Loss","2025-06-01",{"date":320,"type":37},"2025-06-10",{"date":322,"type":21},"2025-06-07",{"date":233,"type":21},{"name":325,"class":44},"Yilai Shu",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":333,"targetDuration":335,"studyType":79,"phases":4,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":45},"100587521","cisplatin-induced-cochlear-and-vestibular-damage-in-head-and-neck-cancer-100587521","NCT06929468","Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer","Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study","Inclusion Criteria:\n\n* Diagnosis of head and neck squamous cell carcinoma\n* Cisplatin-based chemoradiotherapy (monotherapy or combination-therapy, adjuvant or neo-adjuvant) or only radiotherapy (control group)\n* Age 18 to 85 years\n* Signed agreement and willingness to participate in the study and adhere to the study protocol\n\nExclusion Criteria:\n\n* Severe hearing impairment (WHO grade 3 or 4, corresponding to an audiometric ISO value of ≥61 dB in the better ear at frequencies of 500, 1000, 2000 and 4000 Hz)\n* Self-reported tinnitus or vestibular dysfunction in the last 3 months (only lead to exclusion of the corresponding secondary objectives, not to complete exclusion from the study)\n* Current cochlear implant\n* Concurrent treatment with loop diuretics (e.g. furosemide), aminoglycoside antibiotics or other known ototoxic substances in the last three months\n* Acute psychosis or serious psychiatric illness\n* Addiction disorder",{"count":334,"type":21},55,"6 Months","The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.",[338,339,340,341,342,343,344,345,346,27,82],"Ototoxic Hearing Loss","Ototoxicity, Drug-Induced","Cisplatin-induced Hearing Loss","Cisplatin Ototoxicity","Head and Neck Cancer","Dizzyness","Inner Ear Hearing Loss","Vestibular Disease","Squamous Cell Carcinoma of the Head and Neck","2025-04-14",{"date":349,"type":37},"2025-04-16",{"date":351,"type":21},"2025-07",{"date":353,"type":21},"2027-06",{"name":355,"class":44},"Simon Jäger",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":141,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":380,"locationsCount":4},"100585468","adaptation-and-normalization-of-a-verbal-episodic-memory-test-in-french-sign-language-100585468","NCT06902753","Adaptation and Normalization of a Verbal Episodic Memory Test in French Sign Language","Adaptation and Normalization of a Verbal Episodic Memory Test (16-item Free and Cued Recall \u002F RL-RI 16) in French Sign Language","RL-RI-LSF","Inclusion Criteria:\n\n* Person aged ≥ 18 yo\n* with severe or profound deafness (hearing loss ≥ 70 decibels)\n* whose main language is French Sign Language\n* able to consent in writing after a clear explanation of the procedure\n* affiliated to the French Healthcare system (Sécurité Sociale) through self or another person\n\nNon-inclusion criteria:\n\n* person with a medical history in neurology (stroke, traumatic brain injury, dementia) or psychiatry bipolar syndrom or schizophrenia that would not be medicated, severe depression)\n* persons with medical developmental backgroung (e.g genetic syndrome)\n* person with cancer history needing chemotherapy\n* person with a diagnosed and untreated sleeping trouble\n* person drinking \\> 10 glasses of alcohol per week or using drugs on a daily basis\n* person with visual issues\n* person under 18yo or unable to take decisions for self\n\nExclusion Criteria:\n\nA score ≤ 20\u002F28 or 17\u002F28 at the MMS-LS test, depending on the schooling of the participant (20\u002F28 for participants with a degree, 17\u002F28 for participants without a degree)",{"count":365,"type":21},120,[24],"To date, neuropsychological assessment of deaf signing persons is complicated by a lack of resources, especially the absence of tools available in French Sign Language (LSF). This is due to perceptual and cultural differences, and in particular the linguistic differences between French and LSF.\n\nThis lack of resources significantly hinders access to care for deaf patients, as neuropsychological assessment is often a key clinical criterion in the diagnosis of certain neurological pathologies (Alzheimer's disease in particular) and enables coherent care plans to be drawn up, for example in the aftermath of strokes or traumatic brain injuries.\n\nIn particular, episodic memory (which refers to the ability to memorise information anchored in a specific context) is a cognitive domain that is sensitive to pathologies such as Alzheimer's disease, but it is not currently possible to assess it with deaf signing patients.\n\nThe aim of this study is to create a memory assessment test adapted to a deaf population that expresses in LSF and to normalize this test on this same population.\n\nThe aim is to provide a diagnosis assessment tool, which currently does not exist in France, to improve access to care for deaf people. This project could then be extended to the creation of tests for other cognitive domains (executive functions, attention, social cognition, etc.) and to prospects for cognitive remediation.\n\nThe 16-item Free and Cued Recall test (RL-RI 16) is the best choice because it is easy to use and accurate enough to assess each stage of episodic memory. These qualities make it a decisive tool in certain differential diagnosis.\n\nIn order to select the most relevant signs, lexical lists by frequency in LSF will be drawn up during a preliminary phase, during which the participants will have to give, in one minute, the maximum number of signs belonging to different categories (animals, vegetables, clothes...). These lists will be used to select the most relevant signs according to their frequency (neither too common nor too rare), based on the same principle as RL-RI 16.\n\nIt will then be standardised on deaf adults, for whom LSF is the main language, with no cognitive impairment, across France, via the various Deaf Care Units, with the help of French \u002F LSF interpreters. Working with different centers in France will make it possible to recruit a larger and more representative number of participants, and to be more sensitive to any regional effects.",[369,370,371,27,372,373],"Neuropsychological Tests","Memory","Alzheimer Disease","Sign Language","Cognitive Impairment","2025-03-24",{"date":376,"type":37},"2025-03-30",{"date":378,"type":21},"2025-04",{"date":233,"type":21},{"name":381,"class":44},"Poitiers University Hospital",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":17,"minAge":389,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":45},"100400547","restauration-of-the-auditory-and-cognitive-functions-in-cochlear-implanted-deaf-children-in-fnirs-100400547","NCT04495660","Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS","HearCog","Inclusion Criteria:\n\n* Inclusion criteria:\n\nCohort 1 :\n\n* 10-24 months old children will be included.\n* All participants have to be affiliated to the social health security system and parental consent is obligatory.\n* All congenitally deaf patients will have a severe to profound hearing loss and about to be fitted with a cochlear implant.\n* Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.\n\nCohort 2 :\n\n* 3-7 years old children will be included.\n* All participants have to be affiliated to the social health security system and parental consent is obligatory.\n* All congenitally deaf patients will have a cochlear implant, and they will have been implanted before 2 years of age.\n* Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.\n\nExclusion Criteria:\n\n* Exclusion criteria include psycho-neurological diseases, other sensorineural or motor deficiency, familial bilingualism, medications affecting vigilance and child whose both parents benefit from a legal protection measure","10 Months","7 Years",{"count":392,"type":21},80,[24],"The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing subjects (NHS). To do this, the investigator will use functional Near InfraRed Spectroscopy (fNIRS) during 4 tasks that engage the childs perceptual and cognitive skills over a period of 18 months. The performance scores obtained by each participants as well as the cortical activity will be analysed and decrypted.",[27],[397,398,399],"Functional Neuroimaging","Profound and Severe Hearing Loss","Cochlear implant","2024-10-21",{"date":402,"type":37},"2024-10-23",{"date":404,"type":37},"2020-05-29",{"date":406,"type":21},"2026-06-03",{"name":43,"class":44},{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":17,"minAge":335,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":419,"briefSummary":422,"conditions":423,"keywords":430,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":256},"100544551","phase-1-a-phase-iii-clinical-trial-with-sens-501-in-children-suffering-from-severe-to-profound-hearing-loss-due-to-otoferlin-otof-mutations-100544551","NCT06370351","A Phase I\u002FII Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations","A Phase I\u002FII, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children with Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations","AUDIOGENE","Inclusion Criteria:\n\n* Children (male or female) ≥ 6 to ≤ 31 months at the time of inclusion\n* Severe to profound hearing loss assessed by auditory brainstem response (ABR)\n* Biallelic mutation in the Otoferlin gene\n* Presence of Otoacoustic emissions (OAEs)\n* Documented normal cochlea and internal auditory canals\n* Patients with intact vestibular function\n\nExclusion Criteria:\n\n* History of chronic, acute, or major disease, or unspecified reasons, that in the opinion of the Investigator, makes the participant unsuitable for participation in the study or constitutes an unacceptable risk.\n* Have been dosed in a previous gene therapy clinical trial\n* Patients with a prior or current cochlear implant\n* Any contraindication to the surgery determined by the surgeon or anesthesia determined by the anesthesiologist, or designee, or history of therapy known as ototoxic (e.g., cisplatin, high dose and long treatment with aminoglycosides, etc.) for an extended period (more than 2 weeks).\n* Participation in any other interventional clinical trial\n* Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study or might interfere with the evaluation of study treatment\n* Anticipated noncompliance with the protocol requirements","31 Months",{"count":418,"type":21},12,[420,421],"PHASE1","PHASE2","This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.",[424,425,426,427,428,429,27,114],"OTOF Gene Mutation","DFNB9","Congenital Deafness","Hearing Disorders","Ear Diseases","Otorhinolaryngologic Diseases",[424,431,27,432,414,82,425,433,399,434,435,436],"Hearing impairment","otoferlin","Hearing disorder","SENS-501","Congenital Hearing loss","Gene therapy","2024-09-23",{"date":439,"type":37},"2024-09-26",{"date":441,"type":37},"2024-06-21",{"date":443,"type":21},"2031-07",{"name":445,"class":446},"Sensorion","INDUSTRY"]