[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583749":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: audio-proprio-phonatory training (phase 1) then no training (phase 2)","EXPERIMENTAL","Patients will undergo audio-proprio-phonatory training and evaluate their discomfort using the VAS-D scale for a duration of five weeks. Following this period, they will be assessed with the THI score and undergo HD EEG examination (T1). Subsequently, there will be no training and patients will again evaluate their discomfort using the VAS-D score over the next five weeks. At the conclusion of the ten weeks of follow-up, patients will be assessed with the THI score.",[13,14],"Behavioral: The intervention is an audio-proprio-phonatory training","Diagnostic Test: high-density electroencephalogram (HD-EEG)",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2: No training (phase 1) then audio-proprio-phonatory training (phase 2)","Patients will be no training and evaluate their discomfort using the VAS-D scale for a duration of five weeks. Following this period, they will be assessed with the THI score and undergo HD EEG examination (T1). Subsequently, there will undergo audio-proprio-phonatory training and patients will again evaluate their discomfort using the VAS-D score over the next five weeks. At the conclusion of the ten weeks of follow-up, patients will be assessed with the THI score.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The intervention is an audio-proprio-phonatory training","The audio-proprio-phonatory training involves engaging in group workshops and performing exercise sessions independently, following the guidance provided by the specialist, over a duration of five weeks",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DIAGNOSTIC_TEST","high-density electroencephalogram (HD-EEG)","HD-EEG examination with 256 channels distributed throughout the skull that record resting brain connectivity(10 min).",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Isabelle Dr MARIE-BAILLY, PhD","CHU Orléans","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","2 38 74 43 28","+33","isabelle.marie-bailly@chu-orleans.fr",[43],{"facility":44,"status":45,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CHU Orleans","RECRUITING","Orléans","45067","France","FR",{"type":51,"coordinates":52},"Point",[53,54],1.90407,47.90248,{"lat":54,"lon":53},[57],{"name":33,"role":38,"phone":58,"phoneExt":40,"email":41},"238744328",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100583749","neuromodulatory-effects-of-audio-proprio-phonatory-reinforcement-training-on-subjective-tinnitus-demonstrated-by-high-density-electroencephalogram-hd-eeg-100583749",false,"NCT06880367","Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)","PHONACOU","Inclusion Criteria:\n\n* Person who agreed to participate in the study and gave consent\n* Aged ≥ 18 years and \\\u003C 85 years\n* Suffering from subjective tinnitus for more than 3 months\n* Have a score on the THI questionnaire taken at T0 greater than or equal to 38\n* Be equipped with a smartphone compatible with the Siopi application and a computer connection for videoconference sessions\n* Have answered the questionnaires on the Siopi application: THI, VAS-D and associated questions and insomnia severity index\n* Have committed to diligently following the study protocol, including independent training\n* Have agreed not to take other new treatments for tinnitus throughout the duration of the study\n* Able to understand and carry out assessment instructions.\n\nExclusion Criteria:\n\n* Patient suffering from objective tinnitus\n* Current port of white noise generators\n* Patient having consulted phoniatrics more than twice or having participated in more than two sound-mediated workshop sessions\n* Bilateral hearing loss \\> 40 dB uncorrected on an audiogram or having declared serious or severe hearing loss on Siopi questionnaire, with or without prosthetic correction\n* New therapy introduced less than 2 months ago\n* Psychatric disorders causing auditory hallucinations\n* Protected person (under guardianship or curatorship)\n* Person under judicial protection\n* Person deprived of liberty\n* Person not affiliated to a social security system\n* Pregnant or breastfeeding woman\n* Person participating in a drug study","ALL","18 Years","84 Years",{"count":72,"type":73},56,"ESTIMATED","INTERVENTIONAL",[76],"NA","Our ecological approach to neuromodulation in the field of \"acouphonology\" empowers tinnitus patients to act as their own source of sound stimuli through audio-proprio-phonatory reinforcement (APPR). By engaging in self-phonations, individuals uncoverthe vast potential for sound production, which can effectively mask their tinnitus or induce residual inhibition, all without relying on external sources.\n\nThis clinical study aims to illustrate the positive impact of audio-proprio-phonatory reinforcement training on individuals suffering from chronic subjective tinnitus. This will be further supported and quantified through high-definition electroencephalography (HD EEG) as we explore the relationship between changes in connectivity within specific brain regions and the varying degrees of response to the therapeutic protocol.",[79],"Tinnitus, Subjective",[81,82,83,84],"Subjective tinnitus","neuromodulation","audio-proprio-phonatory reinforcement","high-density electroencephalogram","2025-12-22",{"date":87,"type":88},"2025-12-30","ACTUAL",{"date":90,"type":88},"2025-03-18",{"date":92,"type":73},"2028-09-18",{"name":5,"class":6},1]