[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471348":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":42,"collaborators":44,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":88,"overallStatus":94,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":25},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous Vagus Nerve Stimulation Paired with Tailor-Made Notched Music Therapy","EXPERIMENTAL","The participants receive 30 minutes \u002F time, 4 times \u002F day, continuous 3 months of auditory tVNS combined with TMNMT. The stimulation intensity used in each course was set to the highest level that the patient could tolerate. The participants listen to the tailor-made notched music at the same time.",[13],"Device: Transcutaneous Vagus Nerve Stimulation Paired with Tailor-Made Notched Music Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Tailor-made Notched Music Training","ACTIVE_COMPARATOR","Similarly, 30 minutes \u002F time, 4 times \u002F day, continuous 3 months of TMNMT is received every day. The setting of parameters and the selection of music were the same as those in the experimental group. At the beginning of TMNMT, 10 s of sham stimulation set according to the standard of the experimental group is given.",[19],"Device: Tailor-made Notched Music Training",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The pulse frequency of vagus nerve stimulation is 25 Hz, the pulse width is 200 US, and the intensity is 1-10 mA. Tailor-made notched music is produced by filtering a frequency band of 1\u002F2 octave width centered at the individual tinnitus frequency. When two sides of tinnitus frequencies are different, each side of music are filtered respectively, according to the different tinnitus frequency. When only have unilateral tinnitus or bilateral tinnitus in the same central frequency, both sides of music are filtered with the same tinnitus frequency. The tVNS and TMNM begin at the same time during treatment.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Tailor-made notched music is produced by filtering a frequency band of 1\u002F2 octave width centered at the individual tinnitus frequency. When two sides of tinnitus frequencies are different, each side of music are filtered respectively, according to the different tinnitus frequency. When only have unilateral tinnitus or bilateral tinnitus in the same central frequency, both sides of music are filtered with the same tinnitus frequency. At the beginning of TMNMT, 10 seconds sham vagus nerve stimulation is output, whose parameters are as same as experimental group.",[15],[30],{"name":31,"affiliation":5,"role":32},"Yuexin Cai Cai","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Yuexin Cai Cai, Doctor","CONTACT","+8613825063663","panada810456@126.com",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Zhaopeng Tong Tong, bachelor","tongzhp@mail2.sysu.edu.cn",{"type":43,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[45,47,49,52,54,56,58,60],{"name":46,"class":6},"The First Affiliated Hospital with Nanjing Medical University",{"name":48,"class":6},"Zhongshan People's Hospital, Guangdong, China",{"name":50,"class":51},"Affiliated Zhuhai Hospital of Southern Medical University","UNKNOWN",{"name":53,"class":6},"Guangzhou Panyu Central Hospital",{"name":55,"class":51},"Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University",{"name":57,"class":6},"Eighth Affiliated Hospital, Sun Yat-sen University",{"name":59,"class":6},"Second Affiliated Hospital of Guangzhou Medical University",{"name":61,"class":6},"Southern Medical University, China","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":73,"type":74},388,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80,81,82,83,84,85,86,87],"Tinnitus, Subjective","Vagus Nerve Stimulation","Music Therapy","Double-Blind Method","Female","Male","Humans","Treatment Outcome",[89,90,91,92,93],"Chronic subjective tinnitus","Tailor-made notched music training","Vagus nerve stimulation","Electroencephalogram","Clinical trial","NOT_YET_RECRUITING","2023-11-22",{"date":97,"type":98},"2023-11-27","ACTUAL",{"date":100,"type":74},"2023-11-23",{"date":102,"type":74},"2026-09-01",{"name":5,"class":6}]