[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sensorineural-hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sensorineural-hearing-loss":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,41,68,104,128,152,180,207,231,266,291,312,336,369,390,418,446,469,493,513,534],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100473956","anatomy-based-fitting-in-unexperienced-cochlear-implant-users-100473956",false,"NCT05451628","Anatomy-Based Fitting in Unexperienced Cochlear Implant Users","ABFmulti","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)\n* Post-operative Computed Tomography (CT) scan of the CI electrode available\n* Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available\n* Subject implanted with MED-EL cochlear implant(s)\n* Subjects received a Flex28, FlexSoft or Standard electrode\n* Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side\n* Audio processor not yet activated on the newly implanted side\n* The most apical active electrode contact has to be inserted at least 450°\n* Minimum of 10 active channels can be activated\n* Fluent in the language of the test centre\n* Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure\n\nExclusion Criteria:\n\n* Lack of compliance with any inclusion criteria\n* Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)\n* Implanted with C40+, C40X and C40C\n* Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array\n* Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting \"map\" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.",[26,27],"Cochlear Implants","Sensorineural Hearing Loss","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2022-03-30",{"date":36,"type":20},"2027-01",{"name":38,"class":39},"Universitair Ziekenhuis Brussel","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100643095","protein-biomarkers-and-host-rna-expression-profiles-in-congenital-cytomegalovirus-infection-100643095","NCT07635368","Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection","Inclusion Criteria:\n\n1. Children born between 1 January 2010 and 31 December 2025 with an available neonatal dried blood spot sample collected through the Danish National Newborn Screening Program.\n2. Cases: children with verified congenital CMV infection, defined as a positive CMV PCR result on neonatal dried blood spot, blood, or urine collected within the neonatal period.\n3. Controls: children without evidence of congenital CMV infection selected from the same newborn screening population and matched to cases on sex, gestational age, birthweight, and age at DBS sampling.\n\nExclusion Criteria:\n\n1. DBS samples not approved for research use.\n2. DBS samples with insufficient blood material for RNA expression profiling and\u002For proteomic analyses.\n3. Samples with inadequate analytical quality for molecular or proteomic analyses.",true,"0 Days","28 Days",{"count":51,"type":20},630,"OBSERVATIONAL","This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.",[55,56,57,27,58],"Congenital Cytomegalovirus","Cytomegalovirus Infections","Neonatal Infection","Viral Infection","2026-06-04",{"date":61,"type":32},"2026-06-09",{"date":63,"type":32},"2026-04-21",{"date":65,"type":20},"2026-12-31",{"name":67,"class":39},"Rigshospitalet, Denmark",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100595406","phase-1-first-in-human-randomised-trial-of-rincell-1-in-adults-with-a-cochlear-implant-100595406","NCT07032038","First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant","First In Human, Multi-Center Open-Label Randomized Trial to Assess Safety of Rincell-1 Otic Neural Progenitor Cell-Based Therapy and Standard Care vs Standard Care Alone, in Adults With Neural Hearing Loss Eligible for Cochlear Implantation","Inclusion Criteria:\n\nCohort 1 Only\n\n1. Aged 60-74 years (inclusive) at time of consent\n2. Hearing Loss due to bilateral progressive presbycusis\n3. Approved for unilateral cochlear implantation as per UK NICE criteria (TA566)\n4. Documented threshold of ≥70dB in both ears at 1000, 2000 and 4000 Hz, and ≥50dB in both ears at 500 Hz, at time of eligibility\n\n   Cohort 2 Only\n5. Aged 18-74 years (inclusive) at time of consent\n6. Postsynaptic AN characterised by:\n\n   * normal outer hair cell function evidenced by normal OAEs and\u002For CM response, and aberrant or absent ABRs\n   * disparity between relatively preserved pure-tone audiometric thresholds and significantly impaired speech perception abilities, in individuals who do not receive adequate benefit from acoustic HAs\n7. Approved for unilateral cochlear implantation as per UK NICE criteria TA566 and NHS England SSC1442\n\n   All participants (Cohort 1 and Cohort 2)\n8. Capable and willing to provide written informed consent\n9. History, examination and pre-operative imaging suggesting a healthy middle ear in the ear to be implanted, and a structurally normal and fully patent cochlea with no evidence of a widened vestibular aqueduct\n10. Both ears deemed suitable for cochlear implantation\n11. Pre-operative imaging suggesting adequate access for surgical approach for the injection of Rincell-1\n12. Willingness to be implanted with an Advanced Bionics HiRes Ultra 3D CI and suitable as per device IFU indication\n13. A MoCA-HI score of \\>24\n14. English speaker with sufficient comprehension and expressive language to complete questionnaires and speech tests\n\nExclusion Criteria:\n\nCohort 2 Only\n\n1. ECochG measurements and genetic testing suggestive of synaptopathy or myelinopathy, including but not limited to: Otoferlin, CABP2, SLC17A8, KARS2, DIAPH3, GJB2, OPA1, MPZ, PMP22 or SLC52 A2 and A3 mutations.\n\n   All participants (Cohort 1 and Cohort 2)\n2. History of prelingual hearing loss\n3. History of significant hearing loss caused by infection or head trauma\n4. History of previous cochlear implantation, in either ear\n5. Documented hearing loss secondary to ototoxic medications\n6. Suspected or confirmed hearing loss that is wholly or partly unexplained by anatomic or physiologic abnormalities (non-organic hearing loss)\n7. Evidence of current conductive hearing loss defined as 20dB or greater average air-bone gap over three of the following frequencies: 500, 1000, 2000, 3000 or 4000 Hz\n8. History of diagnosed sudden SNHL, Ménière's disease, otosclerosis, cholesteatoma, acoustic neuroma, meningitis or confirmed\u002Fsuspected autoimmune inner ear disease\n9. In the ear to be implanted, evidence of anatomical or morphological issues apparent on pre-operative imaging including inner, middle and outer ear malformations (including evidence of a hypoplastic\u002Fabsent auditory nerve and\u002For bony\u002Fabsent IAM) and any known factor that may restrict full insertion of the electrode array or injection of Rincell-1\n10. Any known contraindications or concerns about medical fitness for cochlear implantation surgery and the additional surgical steps required for Rincell-1 injection (including BMI ≥35)\n11. Any known contraindications or concerns about suitability for any of the trial medicinal products (refer to section 5.2, the IB, NIMP manual (Protocol Appendix 1) and relevant SmPCs)\n12. Diagnosis of active, moderate to severe autoimmune disorders or any immune disorder requiring immunosuppression in the past 5 years\n13. History of documented severe\u002Fsignificant allergic reaction that required treatment\n14. Malignancy under current active treatment or previous malignancy considered at substantial risk for progression or recurrence during trial interval, as determined by the Investigator\n15. Previous or current CNS neoplasms or head and neck cancer\n16. Previous recipient of a gene therapy, any other type of ATMP, cell or organ transplantation, or recipient of multiple blood transfusions within the past 5 years\n17. Unable to be imaged using X-ray and\u002For MRI (including having any other implanted medical device that is MRI conditional)\n18. Currently pregnant or breastfeeding\n19. Unwilling to follow contraception requirements of the trial\n20. Current or future participation in another interventional research study or any hearing-related research study during the course of trial participation\n21. Diagnosis of any syndrome, disorder or disease that is auditory, neurological, neurocognitive, psychological or developmental in nature (including speech and language disorders and dyslexia) which, in the Investigator's judgement, could impact the trial assessments\n22. Laboratory confirmed pre-formed specific anti-HLA antibodies to the cell product\n23. Any other reason, medical or otherwise, which, in the Investigator's judgment, could interfere with the participant's compliance with the protocol (including undertaking of daily objective testing) or interpretation of the study results, makes participating difficult or burdensome for the participant or compromises participant safety","74 Years",{"count":77,"type":20},20,[79,80],"PHASE1","PHASE2","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:\n\n* 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\n* To evaluate how well Rincell-1 works by measuring changes in the function of auditory neurons.\n* To understand if Rincell-1 can be easily and successfully given at the same time as cochlear implant surgery\n\nParticipants 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.\n\nParticipants 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.",[27,83,84],"Presbyacusis","Auditory Neuropathy",[86,87,88,89,90,91],"neural hearing loss","presbycusis","ANSD","auditory neuropathy","cell therapy","first in human","NOT_YET_RECRUITING","2026-05-11",{"date":95,"type":32},"2026-05-12",{"date":97,"type":20},"2026-05",{"date":99,"type":20},"2028-02",{"name":101,"class":102},"Rinri Therapeutics","INDUSTRY",3,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100595975","perceptual-adaptation-following-cochlear-implantation-aim-3a-100595975","NCT07039435","Perceptual Adaptation Following Cochlear Implantation (Aim 3a)","Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users","Inclusion Criteria:\n\n1. Age 18 or older\n2. No known anatomical abnormalities in either ear\n3. English speaking\n4. Intends to receive a cochlear implant in one ear (or has already received it but it has not been activated).\n5. Normal hearing (or minimal hearing loss) in the contralateral ear\n\nExclusion Criteria:\n\n1. Under age 18\n2. Documented anatomical abnormality of the implanted ear\n3. Non-English speaking\n4. Greater than minimal hearing loss in the contralateral ear.",{"count":112,"type":20},22,[23],"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.",[27,116,117],"Cochlear Implantation","Perceptual Adaptation","2026-04-27",{"date":120,"type":32},"2026-05-01",{"date":122,"type":32},"2024-04-03",{"date":124,"type":20},"2029-07-31",{"name":126,"class":39},"NYU Langone Health",1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100631821","yiyuancong-for-the-treatment-of-sudden-sensorineural-hearing-loss-100631821","NCT07505667","Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss","Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss: A Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Unilateral sudden sensorineural hearing loss (SSNHL) occurring within 72 hours, with a hearing threshold decrease of 20 dB at at least two consecutive frequencies.\n2. Enrollment must be completed within 14 days of the onset of SSNHL.\n3. Males or females aged 18 to 60 years.\n4. Ability to understand the study protocol and comply with regular follow-up visits.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation (breastfeeding).\n2. History of chronic ear disease, prior ear surgery, autoimmune hearing loss, or a confirmed diagnosis of Meniere's disease.\n3. Receipt of corticosteroid therapy for any reason within the previous 30 days.\n4. Presence of autoimmune diseases or chronic inflammatory diseases.\n5. Severe hepatic or renal impairment.\n6. Any other condition that, in the opinion of the investigator, renders the participant unsuitable for inclusion.","60 Years",{"count":137,"type":20},128,[23],"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.\n\nBased 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).",[141,27],"Sudden Hearing Loss","2026-03-26",{"date":144,"type":32},"2026-04-01",{"date":146,"type":32},"2025-11-15",{"date":148,"type":20},"2027-11-15",{"name":150,"class":39},"Guangdong Provincial People's Hospital",5,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100627747","optimizing-cochlear-implant-laterality-in-patients-with-unilateral-vestibular-weakness-100627747","NCT07452653","Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness","Inclusion Criteria:\n\n* Patients over the age of 50 years\n* Bilateral and symmetric moderate to profound sensorineural hearing loss (SNHL). Symmetric SNHL will be defined objectively as no more than 20dB difference at any 2 consecutive frequencies or no more than 15dB difference at any 3 consecutive frequencies on standard audiometry and as no significant difference between the ears to the patient.\n* Unilateral vestibular weakness. Unilateral vestibular weakness will be defined by caloric testing of a greater than 22% difference between ears using bithermal water irrigation.\n* Candidates for cochlear implantation by meeting traditional cochlear implant audiometric criteria.\n* Willingness and ability to comply with scheduled visits and study procedures.\n\nExclusion Criteria:\n\n* Patients with prior unilateral cochlear implantation\n* Asymmetric SNHL\n* Absence of unilateral vestibular weakness\n* Contraindication for caloric testing (including epilepsy, dysconjugate eye movements, and history of ear or eye surgery less than 2 months prior)\n* Alternative reasons for selecting cochlear implant laterality, including external. middle, or inner ear disease, anatomical abnormalities, or retrocochlear pathology\n* Pregnant women\n* Fetuses, neonates, children\n* Prisoners\n* Cognitively impaired adults","50 Years","99 Years",{"count":161,"type":20},10,[23],"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.",[27,165],"Vestibular Hypofunction",[167,168,169,170],"cochlear implantation","sensorineural hearing loss","vestibular hypofunction","vestibular weakness","2026-03-06",{"date":173,"type":32},"2026-03-10",{"date":175,"type":20},"2026-04",{"date":177,"type":20},"2027-12",{"name":179,"class":39},"University of Virginia",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":47,"sex":187,"minAge":17,"maxAge":135,"enrollmentInfo":188,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":127},"100555047","genetic-and-epigenetic-background-of-inner-ear-dysfunction-in-turner-syndrome-100555047","NCT06507007","Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome","EPIHEAR","Inclusion Criteria:\n\n* age between 18 and 60 years old\n\nExclusion Criteria:\n\n* Contraindications for the MRI or CBCT\n* Serious medical disorders\n* Neurological or psychiatric disorders of any kind\n* Use of medication that is known to influence inner ear function\n* Medical history with dizziness or hearing problems (controls only)","FEMALE",{"count":189,"type":20},150,"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).\n\nThe aim is to find out if there are specific DNA methylation patterns and\u002For 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.\n\nThe main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases?\n\nTurner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL).\n\nParticipants will undergo the following tests:\n\n* Ear examinations\n* Hearing tests\n* Balance tests\n* Blood tests\n* MRI scans\n* CBCT (cone-beam computed tomography) scans",[27,192,193],"Turner Syndrome","Inner Ear Disease",[195,196,192,197],"Epigenetics","Sensorineural hearing loss","Inner Ear Dysfunction","2026-01-24",{"date":200,"type":32},"2026-01-27",{"date":202,"type":32},"2025-02-01",{"date":204,"type":20},"2027-07-30",{"name":206,"class":39},"Gødstrup Hospital",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":216,"conditions":217,"keywords":221,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":127},"100620986","phase-2-protective-effect-of-acetylcysteine-against-cisplatinum-induced-ototoxicity-a-randomized-controlled-trial-100620986","NCT07364747","Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged between 18 and 70 years\n* Patients scheduled to receive high-dose cisplatin-based chemotherapy regimens with a projected cumulative cisplatin dose of \\> 200 mg\u002Fm2 and each dose \\> 50 mg\u002Fm2\n* Patients may receive concurrent chemotherapy with non-ototoxic agents\n* Patients may receive concurrent radiation therapy to the skull base, provided the radiation dose does not exceed the toxic threshold for ototoxicity\n* Patients receiving an appropriate antiemetic regimen consisting of Olanzapine or Neurokinin-1 (NK1) receptor antagonists\n* Patients receiving medical treatment at Siriraj Hospital.\n\nExclusion Criteria:\n\n* Patients diagnosed with Nasopharyngeal Carcinoma (CA nasopharynx).\n* Patients with a history of head and neck radiation therapy where the radiation dose to the cochlea exceeded 9 Gy or the dose to the eustachian tube exceeded 50 Gy on both sides.\n* Patients who have received N-acetylcysteine (NAC) within 2 weeks prior to the start of the study.\n* Patients who have received other ototoxic drugs within 2 weeks prior to or during the study, including but not limited to:\n\nAminoglycoside antibiotics, Vancomycin, Loop diuretics (e.g., Furosemide), High-dose Aspirin, Antimalarial drugs (e.g., Quinine)\n\n\\- Patient with a known allergy or hypersensitivity to acetylcysteine.","70 Years",{"count":19,"type":20},[80],"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).",[218,27,219,220],"Cisplatin-induced Ototoxicity","Ototoxicity","Ototoxicity, Drug-Induced",[218,27,219],"2026-01-16",{"date":224,"type":32},"2026-01-23",{"date":226,"type":32},"2024-12-23",{"date":228,"type":20},"2027-03-31",{"name":230,"class":39},"Siriraj Hospital",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":248,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":127},"100599211","comparative-analysis-of-hearing-outcomes-robotic-vs-manual-insertion-of-cochlear-implants-100599211","NCT07081542","Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants","Inclusion Criteria:\n\n* Cochlear implant candidates \\>18 years of age\n* LFPTA (125Hz, 250Hz, 500Hz) \\\u003C80dB\n\nExclusion Criteria:\n\n* Pediatric patients (below the age of 18)\n* LFPTA (125Hz, 250Hz, 500Hz) \\>80dB\n* Revision cases\n* Severe comorbidities that contraindicate surgery.\n* Preexisting cochlear anomalies.\n* Do not speak English or Spanish","80 Years",{"count":239,"type":20},32,[23],"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.\n\nThe 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.\n\nThis study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.",[27,243,116,244,245,246,247],"Bilateral Hearing Loss","Hearing Disorders","Hearing Disorders and Deafness","Inner Ear Disorders","Hearing Impairment",[249,250,251,252,253,254,255,256],"Cochlear Implant","Robotic Cochlear Implant Insertion","Hearing Performance","Speech Perception","Electrocochleography","Hearing Rehabilitation","Postoperative Hearing Outcomes","Minimally Invasive ENT Surgery","2025-12-30",{"date":259,"type":32},"2026-01-02",{"date":261,"type":20},"2026-01-01",{"date":263,"type":20},"2027-01-31",{"name":265,"class":39},"AdventHealth",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":103},"100588058","long-term-follow-up-of-a-cochlear-implant-with-dexamethasone-eluting-electrode-array-100588058","NCT06936449","Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array","Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study","CI-DEX-LTFU","Inclusion Criteria:\n\n* Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.\n* Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.\n* Additional disabilities that may affect the subject's participation or safety during the clinical investigation.\n* Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.\n* Currently participating, or participated within the last 30 days, in another interventional clinical investigation\u002Ftrial involving an investigational drug or device.",{"count":275,"type":20},19,"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.",[27,243],[279,280,281,168],"cochlear implant","dexamethasone","bilateral hearing loss","2025-12-12",{"date":284,"type":32},"2025-12-15",{"date":286,"type":32},"2025-05-05",{"date":288,"type":20},"2028-03",{"name":290,"class":102},"Cochlear",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":127},"100447517","quantification-of-visually-evoked-cortical-potentials-in-individuals-with-hearing-loss-100447517","NCT05107466","Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss","Inclusion\n\n* Subjects will be recruited from the Otolaryngology\u002FAudiology clinic at DHMC with the goal of enrolling subjects with a variety of degrees of hearing loss and central auditory processing dysfunction.\n* Age \\> 18 y\u002Fo.\n* Current and new patients receiving care in the DHMC Otolaryngology clinic or from the employees of Dartmouth College, DHMC, and the community, will be included as allowed under COVID guidelines.\n\nExclusion\n\n* Patients with known brain pathology (e.g., CNS tumors, CVA diagnosis, etc…) will be excluded.\n* Patients with severe neurological or neuropsychological disorders will be excluded.\n* Patients with known seizure history will be excluded.\n* Patients with known blindness will be excluded.\n* The following special populations will not be included:\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners",{"count":298,"type":20},100,"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.\n\nThe \"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.\n\nThe 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.",[27,301],"Hearing Loss",[279],"2025-10-27",{"date":305,"type":32},"2025-10-29",{"date":307,"type":32},"2023-07-28",{"date":309,"type":20},"2026-10-01",{"name":311,"class":39},"Dartmouth-Hitchcock Medical Center",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":127},"100604232","hearing-preservation-in-cochlear-implantation-surgery-100604232","NCT07146841","Hearing Preservation in Cochlear Implantation Surgery","Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial","CIPRES","Inclusion Criteria:\n\n* Severe hearing loss, CI candidate\n* 18 years of age or older\n* normal function of middle ear (i.e. no acute middle ear infections)\n* dutch language proficiency\n* choice for Advanced Bionics implant\n\nExclusion Criteria:\n\n* prior otologic surgery in the implanted ear (excluding tympanostomy tube placement)\n* inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation)\n* retrocochlear pathology present in the auditory system to be implanted\n* neurocognitive disorders\n* sudden deafness",{"count":321,"type":20},48,[23],"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.",[27],[27,116,326,253],"Residual Hearing Preservation","2025-08-21",{"date":329,"type":32},"2025-08-28",{"date":331,"type":32},"2020-01-29",{"date":333,"type":20},"2027-01-01",{"name":335,"class":39},"UMC Utrecht",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":344,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":347,"conditions":348,"keywords":352,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":127},"100533738","vestibular-and-postural-function-in-an-unselected-group-of-children-with-sensorineural-hearing-loss-100533738","NCT06229717","Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss","Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)","VASIC","Inclusion Criteria:\n\n* Children in the age of 3-10 years\n* Uni- or bilateral sensorineural hearing loss \\> 20 dB bone conduction pure tone average measured at frequencies 0.5, 1, 2, 4 kHz\n* Written informed consent from the parents.\n\nExclusion Criteria:\n\n* Previous inner ear surgery\n* Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.\n* Congenital nystagmus\n* Compromised eye muscle mobility\n* VEMP-electrode allergy\n* History of symptomatic head or neck trauma\n* Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)","3 Years","10 Years",{"count":321,"type":20},"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.",[349,350,351,27],"Children, Only","Vestibular Disorder","Vestibular Function",[353,354,355,301,356,357,358,359,360,361],"Vestibular dysfunction","Balance problem","Children","Dizziness","Vestibular assessment","video Head Impulse Test","Vestibular Evoked Myogenic Potential","Computerized Dynamic Posturography","Quality of life",{"date":363,"type":32},"2025-08-26",{"date":365,"type":32},"2025-08-20",{"date":367,"type":20},"2028-12",{"name":206,"class":39},{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":47,"sex":16,"minAge":345,"maxAge":376,"enrollmentInfo":377,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":4},"100594730","sensorineural-hearing-loss-imprint-100594730","NCT07023250","Sensorineural Hearing Loss Imprint","Sensorineural Hearing Loss Imprint on Manual Dexterity and Coordination: Pediatric and Adolescent Innovative Study","Inclusion Criteria:\n\n* Both genders with a clinical diagnosis of severe to profound SNHL only. Their ages were between ten to sixteen years, able to understand simple instructions by sign language, able to use both upper and lower limbs, walk and practice daily living activities independently.\n\nExclusion Criteria:\n\n* Children with cochlear implantation, any cognitive, physical, visual, or neurological conditions (other than SNHI and vestibular impairment), history of previous upper, lower limbs, trunk deformity or surgery. All of these cases were confirmed by medical records and examined by a Physical therapist, Pediatrician, and Audiologist","16 Years",{"count":378,"type":20},45,"this study will investigate the consequences of sensorineural hearing loss on manual dexterity and coordination skills in Children.",[27],"2025-06-12",{"date":383,"type":32},"2025-06-15",{"date":385,"type":20},"2025-06-10",{"date":387,"type":20},"2025-07-20",{"name":389,"class":39},"Cairo University",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":398,"enrollmentInfo":399,"targetDuration":401,"studyType":52,"phases":4,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":416,"locationsCount":127},"100533495","long-term-outcomes-of-children-with-congenital-cmv-in-new-york-state-100533495","NCT06226558","Long-Term Outcomes of Children With Congenital CMV in New York State","Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State","PROACTIVE NYS","Inclusion Criteria:\n\n* Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 - October 1, 2024)\n* cCMV evaluation provided by a designated NYS cCMV clinical referral site\n* Family willing and able to complete all study procedures\n* Study participants meet criteria for one of the following four categories:\n* 1\\. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive\n* 2\\. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive\n* 3\\. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test\n* 4\\. Category 4 (Premature infants with confirmed CMV infection on late positive NBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND Positive cCMV confirmatory test obtained within 14 days of a positive NBS\n\nExclusion Criteria:\n\n* Neonate whose parents refuse participation in the long-term follow-up study","1 Year",{"count":400,"type":20},1000,"2 Years","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.\n\nIn particular, our study will provide new information about many facets of congenital CMV, including:\n\n* Developmental, hearing, neurologic, and vision outcomes\n* The spectrum and timing of symptoms\n* The impact congenital CMV has on the baby and its family\n* 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\n\nThroughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications.\n\nAny child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment.\n\nFamilies 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.",[404,27],"Congenital CMV Infection",[406,407,408,196,409],"Congenital CMV","cCMV","Congenital infection","SNHL","2025-05-12",{"date":412,"type":32},"2025-05-13",{"date":414,"type":32},"2024-02-01",{"date":309,"type":20},{"name":417,"class":39},"Stony Brook University",{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":426,"targetDuration":4,"studyType":21,"phases":428,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":127},"100418840","cochlear-implanted-listening-effort-and-hearing-attention-100418840","NCT04733950","Cochlear Implanted Listening Effort and Hearing Attention","Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants","EffICAtt","Inclusion Criteria:\n\nArm 1: patient with Cochlear Implant\n\n* Having a unilateral Oticon Medical cochlear implant\n* Duration of use of the implant of 6 months or more\n* Disyllabic word recognition score of at least 40% on average in silence, to limit \"floor\" effects in hearing tests.\n* Disyllabic word recognition score not exceeding 30% on the contra-lateral ear alone, aided or not, in silence.\n\nArm 2: volunteers with normal hearing\n\n\\- Normal tonal audiometry for the age\n\nFor both\n\n* Age between 18 and 80 years old\n* Mother tongue : French\n* Normal vision with or without correction\n* Absence of eye pathologies (cataracts, nystagmus, amblyopia, macular degeneration).\n* Not taking psychotropic drugs or drugs affecting the parasympathetic nervous system\n* Absence of pathology or neurological history (especially head trauma, stroke).\n* Information and signing of a consent prior to any act related to research\n\nExclusion Criteria:\n\nFor both groups, ensuring the reliability of the pupillometric measurement (Winn et al., 2018):\n\n* Pathologies of the eye: cataracts, nystagmus, amblyopia, macular degeneration.\n* Taking psychotropic drugs and \u002F or drugs affecting the parasympathetic nervous system\n* Neurological pathology (in particular head trauma or stroke) associated with an alteration of cognitive functions or history thereof that may affect the stability of the gaze, the congruence of eye movements, pupillary dilation or with an alteration of cognitive functions\n\nOthers criteria:\n\n* No affiliation (or being entitled) to a social security scheme\n* Person under State Medical Assistance\n* Person under legal protection (tutorship, curatorship, other…) or under family authorization",{"count":427,"type":20},170,[23],"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.\n\nThe 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.\n\nSelective 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.\n\nThe 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).\n\nThis 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.",[27],[432,433,434,435,436],"Cochlear implant","Listening effort","Auditory attention","Pupil dilatation","Sound Modulation","2025-01-10",{"date":439,"type":32},"2025-01-13",{"date":441,"type":32},"2021-12-08",{"date":443,"type":20},"2026-02-22",{"name":445,"class":39},"Assistance Publique - Hôpitaux de Paris",{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":47,"sex":16,"minAge":135,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":21,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":127},"100520178","effects-of-clear-speech-on-listening-effort-and-memory-in-sentence-processing-100520178","NCT06053190","Effects of Clear Speech on Listening Effort and Memory in Sentence Processing","Understanding the Effects of Listening Effort on Sentence Processing and Memory in Sensorineural Hearing Loss: Evidence From Simultaneous Electrophysiology and Pupillometry (Study 2)","Inclusion Criteria:\n\n* Age 60-90\n* Right-handed\n* Native English speaker\n* Scores in the normal range (\\> or = 25 points) on Montreal Cognitive Assessment (MoCA)\n* For adults with hearing loss, a pure-tone average score of \\> 25 dB HL (between 1 - 4kHz)\n\nExclusion Criteria:\n\n* Left-handed (language-related electrophysiological responses of left-handed subjects differ from those of right-handed subjects)\n* History of psychiatric or neurological illnesses (including skull fractures, as this is known to alter electrophysiological response at the scalp)\n* Score of \\\u003C 25 points on the MOCA\n* Use of certain prescription and non-prescription drugs known to alter brain function and the autonomic nervous system, including pupil dilation (e.g., anti-depressants, attention deficit hyperactivity disorder drugs)\n* Any eye disease that would impair the ability to measure pupil dilation (e.g., cataracts, nystagmus, amblyopia)\n* Scores on speech shadowing audibility control task below 50%, suggesting poor intelligibility\n* A display of behavior that would significantly interfere with the validity of data collection or safety during the study;","90 Years",{"count":455,"type":20},80,[23],"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.",[459,460,27],"Speech","Memory, Delayed","2025-01-09",{"date":439,"type":32},{"date":464,"type":32},"2023-09-12",{"date":466,"type":20},"2025-03-01",{"name":468,"class":39},"University of Utah",{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":21,"phases":479,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":4},"100570449","early-phase-1-autologous-blood-monocyte-vesicles-for-the-treatment-of-sudden-deafness-100570449","NCT06707389","Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness","A Pilot Study of Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness","Inclusion Criteria:\n\n* Patients aged between 18 and 65.\n* Patients with severe and above unilateral hearing loss who meet the diagnostic criteria for sudden deafness.\n* Patients who suffer sudden deafness within 3 weeks and do not receive intratympanic injection.\n* Patients who fully understand the purpose and requirements of the trial, volunteer to participate in the clinical trial, sign a written informed consent, and is willing to complete the whole trial process according to the trial requirements.\n\nExclusion Criteria:\n\n* Patients with conductive deafness and mixed deafness;\n* Patients with other otologic diseases;\n* Those who have doubts about the treatment plan or have obvious mental and psychological disorders;\n* Patients with severe heart, lung, liver and kidney dysfunction;\n* Patients with severe hematological diseases or tumors (especially those with acoustic neuromas);\n* Those with positive HIV antibody, HBsAg, HCV antibody, or serological examination results for syphilis;\n* Patients with a history of infection within 1 month prior to screening, requiring hospitalization and \u002F or antibiotics, or currently using systemic hormones (corticosteroids), immunosuppressants or cytotoxicity;\n* Patients with a history of immune system diseases or hematological system diseases;\n* Patients with abnormal blood findings, such as abnormal number and morphology of red blood cells, white blood cells and platelets;\n* Patients with severe or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine, and central nervous system diseases;\n* Women during lactation, pregnancy, or possibly pregnancy;\n* Patients with contraindications or allergies to the treatment of this study;\n* Those who have participated in any clinical drug trial in the past 3 months;\n* Patients that the Investigator considers unsuitable to participate in the trial;\n* Patients not suitable for tympanic injection therapy.","65 Years",{"count":478,"type":20},30,[480],"EARLY_PHASE1","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.",[483,27],"Sudden Deafness","2024-12-24",{"date":486,"type":32},"2024-12-27",{"date":488,"type":20},"2024-12-25",{"date":490,"type":20},"2027-06-01",{"name":492,"class":39},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":494,"slug":495,"hasResults":11,"nctId":496,"briefTitle":497,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":21,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":127},"100573419","evaluation-of-extended-wear-hearing-aid-for-mild-hearing-loss-100573419","NCT06746038","Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss","Inclusion Criteria:\n\n* Meets requirements outlined on Lyric Candidacy Form\n* Current Lyric hearing instrument user\n* 18 years of age or older at time of enrollment in the study\n* Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear\n* Good understanding (read\u002Fwrite\u002Fspeak) of the English language\n* Willingness to comply with all study requirements\n\nExclusion Criteria:\n\n* Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF\u002FISF for SRF-469)\n* Difficulty understanding\u002Freading instructions when corrected for vision loss\n* Impairments that would restrict participation in any of the evaluations\n* Ear health conditions present at baseline that prevent immediate device replacement\n* Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol",{"count":161,"type":20},[23],"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.",[27],[504],"extended wear hearing aid","2024-12-18",{"date":484,"type":32},{"date":508,"type":20},"2025-01-15",{"date":510,"type":20},"2025-03-15",{"name":512,"class":102},"Sonova AG",{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":47,"sex":16,"minAge":519,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":532,"locationsCount":127},"100487995","social-influences-on-sensorimotor-integration-of-speech-production-and-perception-during-early-vocal-learning-100487995","NCT05634356","Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning","Inclusion Criteria:\n\n* infants ca. 7-16 months of age at study onset\n* Infants less than 24 months of age (for follow-up visits only)\n* At least one English-speaking or Spanish-speaking parent in the home who can participate in the study\n* Subjects will include infants with typical hearing, hearing loss, or hearing loss remediated by a hearing aid or cochlear implant.\n\nExclusion Criteria:\n\n* infants who are not exposed to English or Spanish in the home\n* infants who do not have a parent who can participate in the study will be excluded (Caregivers who are not parents will not be eligible to participate in the study)","7 Months","24 Months",{"count":522,"type":20},120,[23],"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:\n\n* The parent and infant engage in a free play session in the playroom while the investigator cues the parent to say simple nonsense words;\n* Infants hear playback of the same words during a second phase.",[27,459],"2024-06-17",{"date":528,"type":32},"2024-06-18",{"date":530,"type":32},"2022-10-12",{"date":202,"type":20},{"name":533,"class":39},"University of Southern California",{"id":535,"slug":536,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":21,"phases":543,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":127},"100490748","immunity-after-cochlear-implantation-and-perilymph-molecular-profiles-in-sensorineural-hearing-loss-100490748","NCT05670158","Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss","Study on the Inner Ear Immunisation Post-cohlear Implantation and Perilymph Molecular Profiling in Sensorineural Hearing Loss","PERILOTO","Inclusion Criteria for the \"Cochlear implantation\" group :\n\n* Patients aged 18 years or more\n* Indication for the cochlear implantation surgery according to the criteria of French National Authority for Health (Severe to profound sensorineural deafness with indication for cochlear implant surgery: Intelligibility less than or equal to 50% when performing vocal audiometry tests with Fournier's list in free field with recent devices.)\n* Presence of \"useful\" residual hearing ≤ 80 dB on at least 2 consecutive frequencies (in air conduction) from the range 125, 250, 500, 1000 kHz on pure-tone audiometry\n* Patients given their free and informed written consent\n* Patients affiliated to a French social security system\n\nInclusion Criteria for the \"Control\" group:\n\n* Patients aged 18 years or more\n* Indication for otological surgery of the middle ear (excluding active infectious or inflammatory pathology e.g. myringoplasty, ossiculoplasty, cure for otosclerosis)\n* Normal hearing (non affected inner ear): average hearing loss (mean threshold for the frequencies 500, 1000, 2000, 4000 Hz) ≤ 35 dB in bone conduction\n* Patients given their free and informed written consent\n* Patients affiliated to a French social security system\n\nExclusion Criteria for the \"Cochlear implantation\" group:\n\n* Contraindication to surgery detected during the preoperative assessment\n* Pre-implantation cochlear assessment unfavorable to the implantation surgery\n* Absence of residual hearing shown by preoperative audiometry\n* History of bacterial labyrinthitis or bacterial meningitis\n* Cochlear ossification shown on preoperative imaging\n* Homozygous pathogenic mutations identified by molecular diagnosis of the SCL26A5 (prestin), TECTB (Beta-Tectorin) genes, and heterozygous of the COCH gene (Cochlin) prior to implantation (if available)\n* Vulnerable subject: minors, protected adults as defined by the Public Health Code, pregnant or breastfeeding women, subject under guardianship or subject deprived of liberty\n* Participation in another pharmacological therapeutic interventional clinical research\n\nExclusion Criteria for the Control group:\n\n* Contraindication to surgery detected during the preoperative assessment\n* Fluctuating hearing = fluctuating hearing thresholds on at least one ear (shown by past bone conduction pure-tone audiometries)\n* History of bacterial labyrinthitis or bacterial meningitis\n* Middle ear infection or inflammation on the day of the surgery\n* Chronical immune or inflammatory disease\n* Active viral or bacterial infection on the day of inclusion visit or surgery\n* Fever on the day of the first blood sample\n* Vulnerable subject: minors, protected adults as defined by the Public Health Code, pregnant or breastfeeding women, subject under guardianship or subject deprived of liberty\n* Participation in another pharmacological therapeutic interventional clinical research",{"count":455,"type":20},[23],"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.\n\nThe 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.\n\nThis 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.\n\nFor the group of implanted patients, the follow-up will last for 12 months with 6 visits in total :\n\n* the inclusion visit V0 during which the study will be presented and the consent form will be signed\n* the surgery visit V1 with blood sample and perilymph collection\n* 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.\n\nFor the control group, the follow up will be 6 months long with 4 visits in total arranged during the routine follow-up appointments:\n\n* the inclusion visit V0 during which the study will be presented and the consent form will be signed\n* the surgery visit V1, the 1 month visit V2 and the 6 months visit V3 during which the blood sampling will be performed.",[27],[547,548,549,196,550,551],"Perilymph","Proteomics","Metabolomics","Residual hearing","Cochlear implantation","2024-01-15",{"date":554,"type":32},"2024-01-18",{"date":556,"type":32},"2023-12-07",{"date":558,"type":20},"2027-03",{"name":560,"class":39},"University Hospital, Montpellier"]