[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638423":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":55,"studyPopulation":46,"armGroups":56,"interventions":67,"overallOfficials":46,"centralContacts":76,"locations":82,"responsibleParty":101,"collaborators":46,"id":103,"slug":46,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":46,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":46,"enrollmentInfo":111,"targetDuration":46,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":126,"whyStopped":46,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":46},[9,13,16,20,23,26,29],{"measure":10,"description":11,"timeFrame":12},"Eligibility rate","The number of screened participants who will be eligible.","Pre-intervention",{"measure":14,"description":15,"timeFrame":12},"Recruitment rate","The number of participants enrolled in the study",{"measure":17,"description":18,"timeFrame":19},"Adherence rate","The number of participants in the intervention and control groups who complete the intervention","Immediately post-intervention",{"measure":21,"description":22,"timeFrame":19},"Attrition rate","The percentage of enrolled participants who discontinue participation at any point during the study.",{"measure":24,"description":25,"timeFrame":19},"Engagement rate","The degree of mastery and use of the intervention content, measured by sleep diary data.",{"measure":27,"description":28,"timeFrame":19},"Retention rate","The number of participants who remain in the study",{"measure":30,"description":31,"timeFrame":19},"Acceptability","Participants' perceptions of and satisfaction with the intervention will be assessed through individual interviews.",[33,37,40,43],{"measure":34,"description":35,"timeFrame":36},"Insomnia","Insomnia will be measured by Insomnia Severity Index (ISI) and actigraphy. The total score on ISI ranges from zero to 28 points, with a higher score indicating more severe insomnia. A total score between 0 and 7 indicates no clinical insomnia; a score of 8 to 14 suggests subthreshold insomnia; 15 to 21 indicates moderate insomnia; and 22 to 28 indicates severe insomnia. The actigraphy will be used in this study is Xiaomi Mi Band 10.","Pre-intervention and immediately post-intervention",{"measure":38,"description":39,"timeFrame":36},"Beliefs and attitudes of sleep","Beliefs and attitudes of sleep will be measured by the Dysfunctional Beliefs and Attitudes about Sleep Scale-16 (DBAS-16). The total score of the scale is 16-80 points. The higher the total score, the more correct the belief and attitude towards sleep.",{"measure":41,"description":42,"timeFrame":36},"Depression","Depression will be measured by 15-item Geriatric Depression Scale (GDS-15). The total score on the scale ranges from zero to 15 points, with the total score above eight points indicating the presence of depression. Higher scores indicate more severe depression.",{"measure":44,"description":45,"timeFrame":36},"Anxiety","Anxiety will be measured by Generalized Anxiety Disorder Scale. The total score of the scale is 0-21 points, with no anxiety below 5 points, mild anxiety of 5-9 points, moderate anxiety of 10-14 points, and severe anxiety above 14 points.Higher scores indicate more severe anxiety.",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":52,"maskingDescription":46,"whoMasked":53},"SINGLE",[54],"OUTCOMES_ASSESSOR","This is a two-arm pilot randomized controlled trial evaluating the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline. Sixty participants will be rectuited. Participants in the intervention group will receive a 6-week AI-assisted sleep intervention, while those in the control group will receive usual care. Outcomes including feasibility and acceptability of the AI-assisted sleep intervention, insomnia, beliefs and attitudes of sleep, depression, and anxiety will be measured at baseline and immediately post intervention.",[57,62],{"label":58,"type":59,"description":46,"interventionNames":60},"Artificial Intelligence (AI)-assisted sleep intervention","EXPERIMENTAL",[61],"Behavioral: Artificial Intelligence (AI)-assisted sleep intervention",{"label":63,"type":64,"description":46,"interventionNames":65},"Usual care","ACTIVE_COMPARATOR",[66],"Behavioral: Usual Care",[68,72],{"type":69,"name":58,"description":70,"armGroupLabels":71,"otherNames":46},"BEHAVIORAL","Six weeks of AI-assisted sleep intervention",[58],{"type":69,"name":73,"description":74,"armGroupLabels":75,"otherNames":46},"Usual Care","The standard care participants receive from the healthcare system and\u002For their daily routines to address insomnia symptoms",[63],[77],{"name":78,"role":79,"phone":80,"phoneExt":46,"email":81},"Shanshan Prof. Wang, PhD","CONTACT","+85227664696","shan-shan.wang@polyu.edu.hk",[83],{"facility":84,"status":46,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Qingyuan Second People's Hospital","Qingyuan","Guangdong","511800","China","CN",{"type":91,"coordinates":92},"Point",[93,94],113.03333,23.7,{"lat":94,"lon":93},[97],{"name":98,"role":79,"phone":99,"phoneExt":46,"email":100},"Yuting Xia","+8613940095971","yuting.xia@connect.polyu.hk",{"type":102,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100638423",false,"NCT07588035","Artificial Intelligence (AI)-Assisted Sleep Intervention for Insomnia in Older Adults With Subjective Cognitive Decline","Artificial Intelligence (AI)-Assist Sleep Intervention for Insomnia Among Older Adults With Subjective Cognitive Decline: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* older adults aged ≥ 60 years\n* Subjective cognitive decline questionnaire 9 (SCD-Q9) ≥ 5\n* Montreal Cognitive Assessment (MoCA) ≥ 26. If the number of years of education is less than 12, one point will be added to the total score;\n* with insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and Insomnia Severity Index (ISI) ≥ 8\n* reachable by phone\n\nExclusion Criteria:\n\n* having a previously diagnosed primary sleep disorder, such as sleep apnoea\n* suffering from a severe chronic illness that could contribute to sleep problems (e.g., emphysema)\n* currently undergoing medical, psychological, or psychiatric treatment for sleep disturbances or depression\n* having significant visual or hearing impairments.","ALL","60 Years",{"count":112,"type":113},60,"ESTIMATED","INTERVENTIONAL",[116],"NA","To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline.",[34,119],"Sleep",[121,119,34,122,123,124,125],"Artificial Intelligence","Older adults","Subjective cognitive decline","Pilot randomized controlled trial","Cognitive behavioral therapy for insomnia","NOT_YET_RECRUITING","2026-05-08",{"date":129,"type":130},"2026-05-14","ACTUAL",{"date":132,"type":113},"2026-04-20",{"date":134,"type":113},"2027-09-01",{"name":5,"class":6},1]