[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636967":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":39,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":25,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":25,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":25},{"fullName":5,"class":6},"Emory University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"REPAIR Sleep","EXPERIMENTAL","Caregiver-PLwD dyads randomized to this arm will receive REPAIR Sleep, a 5-week, 60-minute, videoconference-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention. Sessions are delivered once weekly to both members of the dyad together. The intervention targets behavioral and cognitive factors that perpetuate insomnia and is tailored to the needs of caregivers and persons living with dementia.\n\nParticipants will:\n\n* Attend five weekly 60-minute virtual sessions with a trained interventionist\n* Review and complete sleep diaries and daily adherence checklists\n* Wear a wrist actigraph (CentrePoint Insight Watch) for 2 weeks before and during the 5-week intervention\n* Practice CBT-I components between sessions (e.g., stimulus control, sleep compression, relaxation, cognitive strategies, sleep hygiene)",[13],"Behavioral: REPAIR Sleep",{"label":15,"type":16,"description":17,"interventionNames":18},"Healthy Living","ACTIVE_COMPARATOR","Caregiver-PLwD dyads randomized to this arm will receive Healthy Living, a 5-week, 60-minute, videoconference-delivered attention control intervention adapted from the National Institute on Aging's Go4Life program. The content focuses on general health and wellness (e.g., nutrition, physical activity, fall prevention), with sleep hygiene included as one topic. Sleep-specific behavioral and cognitive strategies from CBT-I are not provided in this arm.\n\nParticipants will:\n\n* Attend five weekly 60-minute virtual sessions with a facilitator\n* Receive a manual and workbook with educational materials and exercises\n* Complete health-related journals (e.g., food intake, physical activity, sleep hygiene practices)\n* Wear a wrist actigraph and complete sleep diaries on the same schedule as the intervention arm",[19],"Behavioral: Healthy Living",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","REPAIR Sleep is a dyadic CBT-I program delivered via videoconferencing over 5 weekly sessions (60 minutes each). Core components include:\n\n* Stimulus control: establishing consistent wake times and strengthening the bed-sleep association\n* Sleep compression: gradually adjusting time in bed to improve sleep efficiency, using a milder form appropriate for older adults and PLwD\n* Relaxation training: techniques to reduce physiological and cognitive arousal at bedtime; can be practiced individually or together\n* Cognitive therapy: identifying and modifying unhelpful thoughts and beliefs about sleep and its consequences\n* Sleep hygiene education: optimizing environmental and behavioral factors that influence sleep\n\nThe intervention uses written and recorded agreements and daily logs to support memory challenges in PLwD and to promote consistent practice of sleep behaviors. Both dyad members attend all sessions.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Healthy Living is an attention-matched, 5-week behavioral health education program delivered via videoconferencing. Weekly 60-minute sessions cover:\n\n* Week 1: Healthy aging principles, components of a healthy lifestyle, nutrition basics, budgeting for nutritious meals, meal planning, and food journaling\n* Week 2: Sleep hygiene education, introduction to flexibility exercises and stretches, activity journaling, and goal setting\n* Week 3: Balance exercises, fall prevention strategies (including safe bed exits at night), and weight-bearing aerobic exercise\n* Week 4: Strength training using resistance bands and light weights\n* Week 5: Integration of exercise, nutrition, and sleep hygiene; review and goal setting for continued healthy living The program emphasizes goal setting, progress tracking, and behavioral reinforcement, with dyads encouraged to implement lifestyle changes and discuss successes and challenges during sessions.",[15],[30],{"name":31,"affiliation":5,"role":32},"Glenna Brewster, PhD, RN","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Glenna S Brewster, PhD, RN","CONTACT","(404) 712-9164","glenna.brewster@emory.edu",{"type":32,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Glenna Brewster","Assistant Professor",[43],{"name":44,"class":45},"National Institute on Aging (NIA)","NIH","100636967","repair-sleep-study-100636967",false,"NCT07572565","REPAIR Sleep Study","Testing Cognitive Behavioral Therapy for Insomnia (CBT-I) on Dyadic Sleep in Dementia: A Randomized Control Trial","Inclusion Criteria:\n\nPLwCC and Caregiver\n\n* Have Insomnia Severity Index (ISI) ≥10\n* Have difficulty initiating or maintaining sleep or waking up too early at least three nights per week\n* Have sleep disturbances persisting for at least three months\n* Have daytime impairment (e.g., fatigue, mood disturbance)\n* Community-dwelling\n* Co-residing with each other\n* Have internet access\n* No history of surgery in the past 4 weeks\n\nCaregivers -Regularly assist the care recipient with ≥1 of 7 basic activities of daily living61 or ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months.\n\nPLwD\n\n-Reported or diagnosed cognitive impairment; able to complete simple directives.\n\nExclusion Criteria:\n\nPLwCC or Caregiver:\n\n* A diagnosis of psychosis, major depressive disorder, or bipolar disorder that is not currently treated;\n* Having had substance or alcohol dependency, or active suicidality in the past year\n* Currently have narcolepsy or restless leg syndrome\n* Does shift work\n* Plan trans-meridian travel during the period of data collection blocks\n* Hearing or visual impairment\n\nCaregivers\n\n* Dementia or cognitive impairment.\n* Individuals who are not yet adults\n* Pregnant women\n* Prisoners\n* Individuals who are not able to clearly understand English.","ALL","18 Years",{"count":56,"type":57},120,"ESTIMATED","INTERVENTIONAL",[60],"NA","The goal of this study is to learn whether a videoconference-delivered CBT-I program (REPAIR Sleep) can improve sleep and psychological well-being in caregiver-PLwD dyads. The main questions it aims to answer are:\n\n* Does REPAIR Sleep improve insomnia severity and other sleep outcomes?\n* Does REPAIR Sleep improve psychological outcomes such as mood, stress, and quality of life? Researchers will compare REPAIR Sleep with Healthy Living to see whether REPAIR Sleep leads to greater improvements.\n\nParticipants will:\n\n* Attend five weekly virtual sessions\n* Complete sleep diaries and questionnaires\n* Wear an actigraphy device\n* Complete follow-up assessments over 9 months",[63,64],"Cognition Disorder","Alzheimer Disease",[66,67,68],"Persons living with cognitive changes","Persons living with Alzheimer's disease and related dementias","Cognitive Behavioral Therapy for Insomnia","NOT_YET_RECRUITING","2026-05-01",{"date":72,"type":73},"2026-05-07","ACTUAL",{"date":75,"type":57},"2026-07",{"date":77,"type":57},"2028-06",{"name":5,"class":6}]