[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544114":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":41,"overallOfficials":47,"centralContacts":51,"locations":58,"responsibleParty":79,"collaborators":26,"id":82,"slug":26,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":26,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":26,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"The Third Affiliated hospital of Zhejiang Chinese Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":26},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in resting-state functional connectivity (RSFC)","RSFC will be measured by functional near-infrared spectroscopy (fNIRS).","at baseline (pre-treatment), after 4-week treatment",{"measure":14,"description":15,"timeFrame":12},"Change in hemoglobin signals","Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).",{"measure":17,"description":18,"timeFrame":12},"Change in Tinnitus Severity Grading","Tinnitus Severity Grading is based on relevant expert consensus.",[20,23],{"measure":21,"description":22,"timeFrame":12},"Change in Tinnitus Handicap Inventory score","Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.",{"measure":24,"description":25,"timeFrame":12},"Change in average pure-tone threshold","The average pure-tone threshold will be assessed by pure-tone audiometry.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","This study will recruit 500 subjects with tinnitus. Functional near-infrared spectroscopy (fNIRS) will be employed to examine specific brain regions, and the corresponding fNIRS imaging data from all detection channels will be extracted. Subsequently, the subjects will undergo a course of acupuncture treatment. Based on the recovery status of tinnitus at the conclusion of the acupuncture course, all subjects will be categorized into a \"good prognosis group\" and a \"poor prognosis group\" according to relevant efficacy criteria. The entire dataset will then be randomly divided into a training set (70%) and a test set (30%) following a 7:3 ratio.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"The acupuncture group","EXPERIMENTAL","Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.",[40],"Procedure: acupuncture",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":26},"PROCEDURE","acupuncture","Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc.",[36],[48],{"name":49,"affiliation":5,"role":50},"Hantong Hu, M.D","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Xiaohan Huang, M.M","CONTACT","18334334738","86","1215360683@qq.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"the Third Affiliated Hospital of Zhejiang Chinese Medical University","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":68,"coordinates":69},"Point",[70,71],120.16142,30.29365,{"lat":71,"lon":70},[74,77,78],{"name":49,"role":54,"phone":75,"phoneExt":56,"email":76},"18667103032","413351308@qq.com",{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},{"name":49,"role":50,"phone":26,"phoneExt":26,"email":26},{"type":50,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hantong Hu","M.D.","100544114",false,"NCT06364670","Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus","Inclusion Criteria:\n\n* Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.\n* Male and female, aged between 18 and 60 years.\n* Right-handed subjects who are able to comply with the study protocol and sign written informed consent.\n* Not participating in other clinical trials concurrently.\n\nExclusion Criteria:\n\n* Participants with objective tinnitus.\n* Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by fNIRS.\n* Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.\n* Participants have any contraindications for acupuncture (such as a bleeding tendency).\n* Pregnant or lactating women.\n* Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.","ALL","18 Years","60 Years",{"count":91,"type":92},500,"ESTIMATED","INTERVENTIONAL",[28],"This trial aims to use machine learning to analyze fNIRS imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for SNT.",[97],"Tinnitus",[44,99,100,101,102],"moxibustion","tinnitus","fNIRS","machine learning","2024-04-12",{"date":105,"type":106},"2024-04-15","ACTUAL",{"date":108,"type":92},"2024-05",{"date":110,"type":92},"2026-12-31",{"name":5,"class":6},1]