[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100466935","anatomy-based-fitting-in-cochear-implant-users-100466935",false,"NCT05360212","Anatomy-based Fitting in Cochear Implant Users","Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.","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-OP CT scan of the CI electrode available\n* Subject implanted with MED-EL cochlear implant(s)\n* Subjects received a Flex28 or FlexSoft electrode\n* Subject planned to receive a SONNET 2 \u002FRONDO3 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 Spanish\n* Signed and dated ICF before the start of any study-specific procedure\n\nSpecific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2\u002FRONDO3 audio processor on the first ear implanted\n\n* 40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side\n* 40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion\n\n  • Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)\n\n  • SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB\n\n  • Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB\n\nExclusion Criteria:\n\n* Lack of compliance with any inclusion criteria\n* EAS user (user of an EAS audio processor)\n* Implanted with C40+, C40X and C40C\n* Implanted with an ABI or Split electrode array\n* Known allergic reactions to components of the investigational medical device\n* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study",true,"ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.",[27,28,29],"Cochlear Implant","Outcomes","Quality of Life","RECRUITING","2025-08-06",{"date":33,"type":34},"2025-08-12","ACTUAL",{"date":36,"type":34},"2022-03-11",{"date":38,"type":21},"2026-12-31",{"name":40,"class":41},"Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100463821","analysis-of-musical-and-voice-skills-in-children-and-adult-cochlear-implant-users-100463821","NCT05319678","Analysis of Musical and Voice Skills in Children and Adult Cochlear Implant Users","Inclusion Criteria:\n\n* Minimum age of 6 years.\n* Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure adequate CI performance).\n* Minimum 12 months experience with the device\n* Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and a hearing aid in the other)\n* At least 80% of electrodes active at the time of assessment.\n* Fluency in Spanish\n* Signed and dated informed consent prior to starting any study procedure.\n\nExclusion Criteria:\n\n* Not meet inclusion criteria.\n* Prelingual or perilingual adults.\n* Disability in addition to hearing impairment (e.g., mental disability).","6 Years",{"count":51,"type":21},80,"12 Months","OBSERVATIONAL","Aims: To evaluate the perception and enjoyment of music in cochlear implant (CI) users using specific questionnaires, and comparing their results with a control group of subjects with normal hearing (NH). To analyze the musical abilities of implantees using the musical tool Meludia, and compare the results with the control group. To perfom a voice analysis in implanted patients, compare it with their NH peers, and check if an association with musical perception is observed.\n\nDesign: Cross-sectional study, both the CI recipients and NH control subjects were assessed once.\n\nSetting and subjects: Pre-or perilingual patients aged 6 to 17 years old, and postlingual adults who underwent cochlear implantation from 2000 to January 2023 at La Paz University Hospital. Control group is set up with their NH peers.\n\nStudy Variables: Socio-demographic and clinical (current age, age at implantation, sex, educational level) variables will be collected, as well as hearing loss (aetiology, duration of deafness), and surgical (type of implant, complete or partial insertion of the electrodes, date of surgery) data. Data from CI fitting (number of active electrodes, type of audio processor) and hearing outcomes with the CI will also be reviewed.\n\nOutcome variables: Specific musical skills questionnaires for adults: Munich Music Questionnaire (MuMu) and Music Related Quality of Life Questionnaire (MuRQoL), which will be validated. Musical questionnaire developed specifically for subjects between 6-17 years old. Musical tool (Meludia) to assess musical perception. Praat software for voice analysis. Analysis of the impact of the different audiological, sociodemographic and clinical variables on hearing outcomes, and on musical perception after cochlear implantation, and comparison with the NH control group.",[27,56,57],"Music","Voice",{"date":33,"type":34},{"date":60,"type":34},"2022-02-10",{"date":62,"type":21},"2025-12-31",{"name":40,"class":41},""]