[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"double-blind-method\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:double-blind-method":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100471348","efficacy-of-transcutaneous-vagus-nerve-stimulation-paired-with-tailor-made-notched-music-therapy-versus-tailor-made-notched-music-training-for-chronic-subjective-tinnitus-100471348",false,"NCT05417711","Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus","Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients with tinnitus as the main complaint: the patients subjectively feel the sound in the ear or deep part of the head without internal or external sound stimulation, and therefore seek medical treatment\n* Chronic (≥ 6 months) and tonal tinnitus\n* Age 18-60\n* Tinnitus frequency is 125-8000 Hz\n* Hearing threshold at each frequency shall not exceed 70 dB HL\n\nExclusion Criteria:\n\n* Patients with conductive deafness, history of middle ear surgery, pulsatile tinnitus caused by vascular distortion and tinnitus caused by Meniere disease\n* History of head trauma, central nervous system diseases, mental diseases and drug abuse","ALL","18 Years","60 Years",{"count":20,"type":21},388,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical study is a prospective, multicenter, randomized, controlled, double-blind clinical study. Sun Yat Sen Memorial Hospital of Sun Yat sen University was the central unit, and Nanjing First Hospital, Sun Yat Sen people's Hospital, Guanfzhou Panyu central Hospital and Zhuhai integrated traditional Chinese and Western medicine hospital were the cooperative units. In this study, 388 patients with chronic subjective tinnitus were recruited. In view of chronic subjective tinnitus, a common ear disease, the study gave the patients three months of treatment with transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy or tailor-made notched music training alone. By comparing the changes of subjective scale scores related to tinnitus before and after treatment in patients receiving two different therapies, such as THI, VAS, BAI, BDI, PSQI, to evaluate the efficacy of the two therapies, so as to judge whether transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy is better than tailor-made notched music training alone. In addition, the study will continue to follow up the patients after the treatment for one year to observe the difference in the long-term sustained efficacy of the two therapies. This clinical study will also evaluate the two therapies from the perspective of compliance and safety, and explore the factors that affect the efficacy of the two therapies.",[27,28,29,30,31,32,33,34],"Tinnitus, Subjective","Vagus Nerve Stimulation","Music Therapy","Double-Blind Method","Female","Male","Humans","Treatment Outcome",[36,37,38,39,40],"Chronic subjective tinnitus","Tailor-made notched music training","Vagus nerve stimulation","Electroencephalogram","Clinical trial","NOT_YET_RECRUITING","2023-11-22",{"date":44,"type":45},"2023-11-27","ACTUAL",{"date":47,"type":21},"2023-11-23",{"date":49,"type":21},"2026-09-01",{"name":51,"class":52},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER"]