[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615655":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":49,"locations":58,"responsibleParty":118,"collaborators":25,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":25,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":151,"whyStopped":25,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"BELL Therapeutics Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BELL-001 Digital Therapeutic","EXPERIMENTAL","Participants assigned to the experimental arm will use BELL-001, a smartphone-based digital therapeutic designed to provide personalized auditory stimulation synchronized with the user's breathing pattern. The intervention is administered nightly during the pre-sleep period for 4 weeks. The device delivers an active algorithm intended to reduce pre-sleep hyperarousal and support sleep initiation.",[13],"Device: BELL-001 Digital Therapeutic",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Digital Therapeutic","SHAM_COMPARATOR","Participants assigned to the sham arm will use a visually identical digital device that does not deliver the active therapeutic algorithm. The sham device mimics the user interface and appearance of BELL-001 to maintain blinding but provides non-therapeutic audio output. Participants will use the device nightly during the pre-sleep period for 4 weeks.",[19],"Device: Sham Digital Therapeutic",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Participants assigned to the experimental arm will use BELL-001, a smartphone-based digital therapeutic designed to provide personalized auditory stimulation synchronized with the user's breathing pattern. Participants will use the device nightly during the pre-sleep period for 4 weeks. The active algorithm delivers respiratory-synchronized auditory feedback intended to reduce pre-sleep hyperarousal and support sleep initiation.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"A sham version of the BELL-001 software that is visually indistinguishable from the active device but lacks the respiratory-synchronized therapeutic algorithm. It provides non-synchronized audio output and serves as the control condition. Used nightly during the pre-sleep period for 4 weeks.",[15],[30,34,37,40,43,46],{"name":31,"affiliation":32,"role":33},"Ki-Young Jung","Seoul National University Hospital","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Jung-ik Byun","Kyung Hee University Hospital at Gangdong",{"name":38,"affiliation":39,"role":33},"Joon-Sang Sunwoo","Kangbuk Samsung Hospital",{"name":41,"affiliation":42,"role":33},"Kyung-Jin Hwang","Kyunghee University Medical Center",{"name":44,"affiliation":45,"role":33},"Jung-Won Shin","CHA Bundang Medical Center",{"name":47,"affiliation":48,"role":33},"Hye-Yoon Kim","Catholic Kwandong University International St. Mary's Hospital",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":25,"email":54},"Jae-Eun Lee","CONTACT","+82-70-8095-4983","jay.lee@belltherapeutics.com",{"name":56,"role":52,"phone":53,"phoneExt":25,"email":57},"Hye-won Lee","hyewon.lee@belltherapeutics.com",[59,74,82,92,101,109],{"facility":32,"status":25,"city":60,"state":25,"zip":61,"country":62,"countryCode":25,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Seoul","03080","South Korea",{"type":64,"coordinates":65},"Point",[66,67],126.9784,37.566,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":25,"email":73},"Ki-young Jung","02-2072-0707","jungky@snu.ac.kr",{"facility":48,"status":25,"city":60,"state":25,"zip":25,"country":62,"countryCode":25,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},{"type":64,"coordinates":76},[66,67],{"lat":67,"lon":66},[79],{"name":47,"role":52,"phone":80,"phoneExt":25,"email":81},"+82 32-290-3889","imkhy77@gmail.com",{"facility":83,"status":25,"city":60,"state":25,"zip":25,"country":62,"countryCode":25,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"CHA Bundang Hospital",{"type":64,"coordinates":85},[66,67],{"lat":67,"lon":66},[88],{"name":89,"role":52,"phone":90,"phoneExt":25,"email":91},"Jungwon Shin","+82 31-80-3938","limitsum@gmail.com",{"facility":39,"status":25,"city":60,"state":25,"zip":25,"country":62,"countryCode":25,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},{"type":64,"coordinates":94},[66,67],{"lat":67,"lon":66},[97],{"name":98,"role":52,"phone":99,"phoneExt":25,"email":100},"JunSang Sunwoo","+82 2-2001-8525","ultrajs4@gmail.com",{"facility":36,"status":25,"city":60,"state":25,"zip":25,"country":62,"countryCode":25,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},{"type":64,"coordinates":103},[66,67],{"lat":67,"lon":66},[106],{"name":35,"role":52,"phone":107,"phoneExt":25,"email":108},"+82 2-440-6254","mr830611@gmail.com",{"facility":110,"status":25,"city":60,"state":25,"zip":25,"country":62,"countryCode":25,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Kyung Hee University Medical Center",{"type":64,"coordinates":112},[66,67],{"lat":67,"lon":66},[115],{"name":41,"role":52,"phone":116,"phoneExt":25,"email":117},"+82-2-958-8429","Jinie111@hanmail.net",{"type":119,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100615655","sleep-efficacy-randomized-evaluation-of-a-novel-digital-therapeutic-for-insomnia-100615655",false,"NCT07295431","Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia","A Multicenter, Randomized, Double-Blind, Sham-Controlled, Pivotal Clinical Investigation to Evaluate the Efficacy and Safety of the Digital Therapeutic 'BELL-001' for Improving Symptoms in Patients With Insomnia","SERENE","Inclusion Criteria:\n\n* Adults aged 19 to 75 years.\n* Clinical diagnosis of insomnia disorder according to ICD-11 criteria (non-organic insomnia or sleep initiation\u002Fmaintenance disorder).\n* Insomnia Severity Index (ISI) score ≥ 15 at screening.\n* Reports difficulty initiating or maintaining sleep at least 3 nights per week for ≥ 3 months.\n* Willing and able to use a smartphone-based digital therapeutic during the pre-sleep period for 4 weeks.\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Other primary sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders).\n* Major psychiatric disorders that may interfere with study assessment (e.g., psychotic disorders, bipolar disorder, severe major depressive episode).\n* Substance use disorder, including alcohol or hypnotic misuse, within the past 12 months.\n* Use of sleep-inducing medications or CNS-active drugs that cannot be stabilized or discontinued per protocol.\n* Significant medical or neurological conditions that may affect sleep or study outcomes (e.g., severe cardiovascular, respiratory, or neurological disease).\n* Night-shift workers or individuals with irregular sleep-wake schedules.\n* Pregnancy or breastfeeding.\n* Participation in another interventional clinical study within the past 30 days.\n* Any condition judged by the investigator to interfere with study participation, safety, or data validity.","ALL","19 Years","75 Years",{"count":132,"type":133},114,"ESTIMATED","INTERVENTIONAL",[136],"NA","This study is a multicenter, randomized, double-blind, sham-controlled clinical investigation designed to evaluate the effectiveness and safety of BELL-001, a digital therapeutic developed to improve symptoms of insomnia. Insomnia is a common sleep disorder that can significantly affect daytime functioning, mood, and overall quality of life. Many patients continue to have difficulties despite lifestyle changes or medication, and safer, non-pharmacological treatment options are increasingly needed.\n\nBELL-001 is a smartphone-based therapeutic that delivers personalized auditory stimulation during the pre-sleep period. The device is intended to promote relaxation and support the transition into sleep by analyzing individual breathing patterns and providing synchronized sound feedback. The study will compare BELL-001 with a sham (placebo-like) digital device that looks identical but does not provide the active therapeutic functions.\n\nAdults diagnosed with insomnia will be randomly assigned to either the BELL-001 group or the sham group. Participants will use the assigned device for four weeks. Throughout the study, sleep-related symptoms, daytime functioning, fatigue, and quality-of-life measures will be assessed. The primary outcome is the change in Insomnia Severity Index (ISI) scores after four weeks of treatment. Safety will be monitored regularly through participant reports and clinical evaluations.\n\nThis trial is being conducted at multiple hospitals in Korea and follows ethical guidelines, including review and approval by institutional review boards (IRBs). Participation is voluntary, and all individuals will provide informed consent before any study procedures begin. The results of this study are expected to provide key evidence for the clinical use of a digital, non-pharmacological intervention for adults with insomnia.",[139,140],"Insomnia","Sleep Initiation and Maintenance Disorders",[142,143,144,145,146,147,148,149,150],"Digital Therapeutic","BELL-001","Insomnia Treatment","Auditory stimulation","Biofeedback","Sleep Onset Latency","Sham-Controlled Trial","Autonomic Regulation","Breathing-Synchronized Therapy","NOT_YET_RECRUITING","2025-12-18",{"date":154,"type":155},"2025-12-22","ACTUAL",{"date":157,"type":133},"2026-01-15",{"date":159,"type":133},"2026-07-31",{"name":5,"class":6},6]