[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Sun Yat-sen University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100633025","wearable-voice-guided-bbti-for-comorbid-insomnia-and-sleep-apnea-comisa-100633025",false,"NCT07521319","Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)","Wearable Voice-Guided Brief Behavioral Therapy for Insomnia (BBTi) for Comorbid Insomnia and Sleep Apnea (COMISA): Effects on Insomnia Severity and CPAP Adherence From Mechanism Evaluation and Device Development to a Multicenter Randomized Controlled Trial","BBTi-COMISA","Inclusion Criteria:\n\n* Age ≥20 years.\n* Obstructive sleep apnea (OSA) diagnosed by clinical polysomnography (PSG), defined as apnea-hypopnea index (AHI) ≥5 events\u002Fhour.\n* Insomnia disorder diagnosed by a physician according to DSM-5 criteria, with Insomnia Severity Index (ISI) score ≥15.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment,\n* Major psychiatric disorder,\n* Severe chronic illness (e.g., severe heart failure or receiving hemodialysis).\n* Other sleep disorders (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders).\n* Receipt of CBT-I, BBTi, or other behavioral sleep interventions within the past 3 months.\n* Pregnant or breastfeeding.","ALL","20 Years","80 Years",{"count":21,"type":22},361,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study investigates the efficacy of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA). The four-year study comprises three phases: (1) exploration of cognitive-emotion regulation-arousal system mechanisms in COMISA and pilot BBTi intervention testing, (2) development and usability testing of an integrated smart eye-mask with BBTi voice-guided modules, and (3) a multi-center randomized controlled trial (RCT) evaluating the combined BBTi plus smart eye-mask intervention versus BBTi alone, smart eye-mask alone, and standard sleep hygiene education in 160 COMISA participants. Primary outcomes include insomnia severity (ISI), daytime sleepiness (ESS), and CPAP adherence. The study aims to establish an evidence-based digital health intervention for improving sleep outcomes in COMISA patients.",[28,29,30],"Comorbid Insomnia and Sleep Apnea","Insomnia","Obstructive Sleep Apnea",[32,33,34,35,36],"BBTi","COMISA","CPAP","Wearable Device","Sleep","NOT_YET_RECRUITING","2026-04-07",{"date":40,"type":41},"2026-04-09","ACTUAL",{"date":43,"type":22},"2026-08-01",{"date":45,"type":22},"2030-12",{"name":47,"class":48},"National Sun Yat-sen University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100632430","dual-track-residential-exercise-with-ai-and-monitoring-for-sleep-100632430","NCT07513584","Dual-track Residential Exercise With AI and Monitoring for Sleep","Dual-track Residential Exercise With AI and Monitoring for Sleep in Older Adults With Chronic Insomnia (DREAMS Study)","DREAMS","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Capable of independent mobility (without the use of assistive devices).4\n* Meeting one of the following sleep disturbance criteria:\n\nCore symptoms of DSM-5 chronic insomnia (self-reported) for ≥ 3 months. Insomnia Severity Index (ISI) ≥ 15 (moderate-to-severe insomnia). Pittsburgh Sleep Quality Index (PSQI) \\> 5 (poor sleep quality).\n\n* Basic ability to use a tablet or smartphone (caregivers may assist with login, but exercise must be performed by the participant).\n* Mini-Cog score ≥ 3.\n* Consent to wear wearable devices and participate in data collection.\n\nExclusion Criteria:\n\n* Major cardiovascular events within the past 3 months (e.g., acute myocardial infarction, unstable angina), severe heart failure, or uncontrolled hypertension (e.g., SBP ≥ 180 or DBP ≥ 110 mmHg).\n* Severe osteoarticular or neuromuscular diseases that prevent the safe completion of exercise (e.g., recent hip fracture, severe Parkinsonian imbalance).\n* Severe psychiatric disorders or substance use disorders that may affect adherence.\n* Untreated moderate-to-severe obstructive sleep apnea (OSA) with extreme daytime sleepiness (the study will use objective measurements for preliminary screening).\n* Currently receiving structured psychotherapy for insomnia (e.g., CBT-I or BBTi) and not yet stabilized.\n* Severe visual or hearing impairment that prevents following voice or visual instructions.","60 Years",{"count":59,"type":22},60,[25],"As societies rapidly transition toward aging demographics, sleep issues among community-dwelling older adults have emerged as a critical concern affecting healthy aging and independent living. Current single-track exercise intervention models are often difficult to implement due to suboptimal adherence. Therefore, this study aims to utilize artificial intelligence technology combined with a dual-track residential exercise mode to improve sleep quality, thereby enhancing the self-care and independent living abilities of the elderly",[63,64,65,66],"Chronic Insomnia Characterized","Difficulty Falling Asleep","Difficulty Maintaining Sleep","Healthy Aging and Independent Living",[68,69,70,71],"precision health promotion","insomnia phenotyping","adaptive feedback loop","wearable technology","2026-03-30",{"date":38,"type":41},{"date":43,"type":22},{"date":76,"type":22},"2027-07-31",{"name":47,"class":48},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":89,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100620513","eye-movement-parameters-and-cognitive-functions-in-older-adults-100620513","NCT07358598","Eye Movement Parameters and Cognitive Functions in Older Adults","The Relationship Between Eye Movement Parameters and Cognitive Functions in Older Adults","Inclusion Criteria:\n\n\\- Participants are aged 65 years or older and have completed a comprehensive geriatric assessment (CGA) in the outpatient clinic.\n\nExclusion Criteria:\n\n* Participants are under 65 years of age or those who ar are unable to comply with study procedures.",true,"65 Years",{"count":88,"type":22},210,"1 Year","OBSERVATIONAL","Dementia most commonly occurs in elderly individuals, but currently there is still a lack of objective measurement methods that can detect cognitive impairment in older adults at an early stage. Eye movement is considered a clinical indicator with potential for screening mild cognitive dysfunction, and eye movement signals can be extracted to objectively evaluate cognition. Eye tracking has been used mostly to evaluate patients with neurodegenerative diseases such as Parkinson's disease. However, less attention has been paid to the relationship between eye movement and cognitive function in elderly individuals, as well as the association between eye movement data and abnormal cognitive subdomains. This cross-sectional study will recruit 0204 elderly individuals over the age of 65, divided into three groups (healthy group\u002Fmild cognitive impairment group\u002Fdementia group) according to the purpose of this study. Participants who have not been diagnosed with neurological diseases (such as Parkinson's disease or stroke), or have mental illness or visual impairments will be excluded. This study hopes to provide empirical data on eye movement signals and cognitive function in healthy older individuals, as well as to serve as a preliminary study for future development of eye activity stimulation to improve cognitive function in older adults.",[93],"Cognitive Dysfunction",[95,96,97],"Eye movements","Cognitive function impairment","Older adults","2026-01-22",{"date":100,"type":41},"2026-01-23",{"date":102,"type":22},"2026-01-17",{"date":104,"type":22},"2026-12-31",{"name":47,"class":48},1,""]