[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569496":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":25,"locations":31,"responsibleParty":99,"collaborators":11,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":11,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":11,"enrollmentInfo":110,"targetDuration":11,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":11,"overallStatus":120,"whyStopped":11,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"WELT corp","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"digital CBT-I","EXPERIMENTAL",null,[13],"Device: digital CBT-I",{"label":15,"type":16,"description":11,"interventionNames":11},"Waitlist Control","NO_INTERVENTION",[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","The intervention is a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program, delivered via a mobile application. The program includes structured, self-guided modules focusing on sleep hygiene education, cognitive restructuring, stimulus control, bed time restriction, and relaxation techniques. Each module offers interactive exercises and weekly assignments designed to support behavior change and improve sleep. Participants will receive app-based reminders to encourage regular engagement, with features for tracking progress and adherence throughout the 6 week program.",[9],[23,24],"digital cognitive behavioral therapy for insomnia","SleepQ",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Yujin Lee, Chief Medical Officer, MD","CONTACT","+82-2-6439-0707","info@weltcorp.com",[32,49,63,77,88],{"facility":33,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":11,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Inje University Ilsan Paik Hospital","Goyang-si","Gyeonggi-do","10380","South Korea",{"type":39,"coordinates":40},"Point",[41,42],126.835,37.65639,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":11,"email":48},"Pamela Song, MD","+82-31-910-7847","songpama7@gmail.com",{"facility":50,"status":11,"city":51,"state":35,"zip":52,"country":37,"countryCode":11,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Yongin Severance Hospital","Yongin-si","16995",{"type":39,"coordinates":54},[55,56],127.08042,37.29686,{"lat":56,"lon":55},[59],{"name":60,"role":28,"phone":61,"phoneExt":11,"email":62},"Woojung Kim, MD","+82-10-9282-7943","WOOJUNGKIM@yuhs.ac",{"facility":64,"status":11,"city":65,"state":65,"zip":66,"country":37,"countryCode":11,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Severance Hospital, Yonsei University Health System","Seoul","03722",{"type":39,"coordinates":68},[69,70],126.9784,37.566,{"lat":70,"lon":69},[73],{"name":74,"role":28,"phone":75,"phoneExt":11,"email":76},"Eun Lee, MD, PhD","+82-02-2228-1620","leeeun@yuhs.ac",{"facility":78,"status":11,"city":65,"state":65,"zip":79,"country":37,"countryCode":11,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"The Catholic University of Korea, Seoul ST. Mary's Hospital","06591",{"type":39,"coordinates":81},[69,70],{"lat":70,"lon":69},[84],{"name":85,"role":28,"phone":86,"phoneExt":11,"email":87},"Junhee Lee, MD","+82-2-2258-6080","j.lee@snu.ac.kr",{"facility":89,"status":11,"city":65,"state":65,"zip":90,"country":37,"countryCode":11,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Ewha Womans University Medical Center","07804",{"type":39,"coordinates":92},[69,70],{"lat":70,"lon":69},[95],{"name":96,"role":28,"phone":97,"phoneExt":11,"email":98},"Jeehyun Kim, MD","+82\u002F2-6986-3562","jeehkim26@ewha.ac.kr",{"type":100,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100569496","digital-cbt-i-for-chronic-insomnia-100569496",false,"NCT06695000","Digital CBT-I for Chronic Insomnia","A Multi-Site, Randomized, Wait-List Controlled Trial to Assess the Effectiveness and Safety of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) in Patients with Chronic Insomnia","Inclusion Criteria:\n\n* Meets diagnostic criteria for insomnia disorder according to the International Classification of Diseases, 10th Revision (ICD-10), including: F51: Nonorganic sleep disorders; G47: Sleep disorders\n* Has experienced insomnia symptoms for 3 months or longer.\n* Scores 8 or higher on the Insomnia Severity Index (ISI).\n* Oral and written fluency in Korean\n* Owns a smartphone and is independently able to use apps on a smartphone.\n* Voluntarily agrees to participate in this clinical study and provides signed informed consent.\n\nExclusion Criteria:\n\n* Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.\n* Diagnosed with other sleep disorders aside from insomnia and currently symptomatic, such as:\n\n  * Obstructive sleep apnea (G47.30)\n  * Sleep behavior disorders\n  * Restless leg syndrome (G28.8)\n  * Narcolepsy (G47.4)\n* Has an active, ongoing physical illness that impedes daily functioning, such as:\n\n  * Congestive heart failure\n  * Chronic obstructive pulmonary disease (COPD)\n  * Acute pain\n  * Neurological disorders (e.g., cerebrovascular disease)\n  * Neurodegenerative disorders (e.g., dementia, multiple sclerosis)\n  * Unstable medical conditions or life expectancy of less than 6 months\n* Adjustments in schedule or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within the past 3 months, or use of PRN (as needed) prescribed sleep medications.\n* Engaged in shift work.\n* Pregnant individuals or those planning to become pregnant during the study period.\n* Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities","ALL","19 Years",{"count":111,"type":112},120,"ESTIMATED","INTERVENTIONAL",[115],"NA","This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.",[118,119],"Insomnia Chronic","Insomnia Disorder","NOT_YET_RECRUITING","2024-11-15",{"date":123,"type":124},"2024-11-19","ACTUAL",{"date":126,"type":112},"2025-01",{"date":128,"type":112},"2026-03",{"name":5,"class":6},5]