[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544928":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":62,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital CBT-I","EXPERIMENTAL","Preoperative digital CBT-I with the CBT-I Coach app for up to 4 weekly sessions and postoperative booster sessions at 2 weeks and 1 month after surgery.",[13],"Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sleep Health Education","ACTIVE_COMPARATOR","Preoperative sleep health education materials",[19],"Behavioral: Sleep Health Education",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)","Preoperative hybrid intervention (in-person or via phone\u002Fvideo) over 4 weeks, and at 2 weeks, and 1 month after surgery using content from the CBT-I Coach app from Veteran Affairs.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Sleep Health Education materials provided",[15],[31],{"name":32,"affiliation":5,"role":33},"Lei Gao, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Andrea Castillo, BS","CONTACT","4695094163","acastillo17@mgh.harvard.edu",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Mili Jimenez Gallardo","mjimenezgallardo@mgh.harvard.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,61],{"name":32,"role":37,"phone":59,"phoneExt":26,"email":60},"6178882941","lgao@mgh.harvard.edu",{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":33,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Lei Gao, MBBS, MMSc","Associate Professor of Anaesthesia",[66],{"name":67,"class":68},"National Institute on Aging (NIA)","NIH","100544928","digital-sleep-optimization-for-brain-health-outcomes-in-older-surgical-patients-100544928",false,"NCT06375265","Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients","A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)","SLEEP-BOOST","Inclusion Criteria:\n\n1. Adults ≥ 65 years old\n2. Scheduled for an elective orthopedic total joint replacement procedure (knee\u002Fhip)\n3. At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)\n\n5\\. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.\n\nExclusion Criteria:\n\n1. Current or previous CBT-I exposure in the last 6 months prior to the start of the study\n2. Rapidly progressive illnesses\u002Flife expectancy \\\u003C6 months\n3. Active psychosis\u002Fsuicidal ideation\n4. Irregular shift work\u002Fsleep patterns\n5. Moderate-severe sleep apnea (apnea\u002Fhypopnea index ≥15) without CPAP compliance per chart review\n6. Sleep disorders other than insomnia or apnea\n7. Cognitive impairment (diagnosis of dementia)\n8. Initiation, discontinuation, or dose change of sleep-affecting prescription medications within 1 month prior to study start or during the intervention period; not excluded if stable sleep-affecting medications in the prior month (by clinical review)\n9. No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months","ALL","65 Years",{"count":80,"type":81},50,"ESTIMATED","INTERVENTIONAL",[84],"NA","The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).",[87,88,89,90],"Insomnia","Postoperative Delirium","Delayed Neurocognitive Recovery","Postoperative Neurocognitive Disorder","2026-05-11",{"date":93,"type":94},"2026-05-14","ACTUAL",{"date":96,"type":94},"2025-01-15",{"date":98,"type":81},"2026-12-31",{"name":5,"class":6},1]