[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652251":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Internet-based CBT-I Group","EXPERIMENTAL","Participants randomized to the experimental arm will receive an 8-week therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) program. The intervention is designed to improve insomnia symptoms and will be delivered through a smartphone-based online platform. Participants will complete weekly CBT-I modules and related homework assignments during the 8-week intervention period, with follow-up assessments conducted after the intervention.",[13],"Other: Internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I)",{"label":15,"type":16,"description":17,"interventionNames":18},"Patient Education Group","ACTIVE_COMPARATOR","Participants randomized to the comparator arm will receive an 8-week online patient education intervention. The intervention provides general educational information about tinnitus, insomnia, their potential relationship, and general recommendations for sleep and lifestyle management. Participants will have access to the educational materials throughout the 8-week intervention period.",[19],"Other: Online Patient Education",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I)","The internet-based CBT-I intervention will be delivered over 8 weeks through a smartphone-based online platform. The program consists of eight weekly modules incorporating core components of CBT-I, including stimulus control, sleep restriction therapy, cognitive restructuring, relaxation and mindfulness practices, and sleep hygiene education. Participants will complete daily relaxation exercises and weekly homework assignments. Treatment progress will be monitored through the online platform, and trained therapists will review participants' progress and provide feedback during the intervention period.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Online Patient Education","The online patient education intervention will provide non-individualized educational materials covering tinnitus and insomnia, their potential interaction, and general strategies for sleep and lifestyle management. The educational materials will be delivered through a smartphone-based online platform and will remain accessible throughout the 8-week intervention period.",[15],[31],{"name":32,"affiliation":33,"role":34},"Huawei Li, Ph.D","Eye and ENT Hospital of Fudan University","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Xiaoling Huang, MS","CONTACT","+86-15800955305","xiaolingh2023@163.com",[42],{"facility":43,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department","Shanghai","Shanghai Municipality","200031","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100652251","efficacy-of-internet-based-cognitive-behavioral-therapy-for-insomnia-in-patients-with-tinnitus-and-insomnia-100652251",false,"NCT07769515","Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia","A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Insomnia Versus Patient Education in Patients With Tinnitus and Insomnia","Inclusion Criteria:\n\n* Adults aged between 18 and 65 years;\n* Diagnosis of chronic subjective tinnitus persisting for at least 6 months;\n* A score of 38 or higher on the Tinnitus Handicap Inventory (THI);\n* An Insomnia Severity Index (ISI) score of 8 or higher;\n* Ability to understand the study procedures and provide informed consent;\n* Proficiency in reading and writing Chinese;\n* Access to a smartphone for participation in the digital intervention.\n\nExclusion Criteria:\n\n* Objective or pulsatile tinnitus;\n* Specific otologic conditions requiring immediate medical treatment, such as sudden sensorineural hearing loss;\n* Diagnosed organic sleep disorders, such as obstructive sleep apnea;\n* Serious psychiatric disorders, including schizophrenia;\n* Concurrent enrollment in another clinical trial targeting tinnitus or insomnia.","ALL","18 Years","65 Years",{"count":70,"type":71},168,"ESTIMATED","INTERVENTIONAL",[74],"NA","This single-center, single-blind, randomized controlled trial is designed to evaluate the efficacy of therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) compared with patient education in patients with chronic subjective tinnitus and clinically significant insomnia. A total of 168 participants will be randomized in a 1:1 ratio to receive either an 8-week internet-based CBT-I intervention or an online patient education intervention. The primary outcome is the between-group mean difference in Tinnitus Handicap Inventory (THI) score at 2 months after randomization. Secondary outcomes include insomnia severity, subjective sleep parameters, tinnitus loudness, anxiety and depression symptoms, and dysfunctional beliefs and attitudes about sleep. Participants will be assessed at baseline, 1 month, 2 months, 3 months, and 5 months.",[77,78],"Tinnitus","Insomnia","NOT_YET_RECRUITING","2026-08-13",{"date":82,"type":83},"2026-08-18","ACTUAL",{"date":85,"type":71},"2026-08-24",{"date":87,"type":71},"2029-12-30",{"name":5,"class":6},1]