[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527265":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":60,"collaborators":25,"id":62,"slug":25,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":86,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Uppsala University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive behavioral therapy for insomnia (CBT-I)","EXPERIMENTAL","The CBT-I treatment will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a psychologist one time per week. The CBT-I will focus on sleep restriction therapy and stimulus control, which have shown the highest efficacy for sleep improvement among components typically incorporated. A booster session will be provided 1-2 weeks postoperative.",[13],"Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sleep education therapy (SET)","ACTIVE_COMPARATOR","The sleep education therapy will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a research nurse one time per week. The SET will focus on sleep physiology, different sleep disturbances and sleep hygiene measures. A booster session will be provided 1-2 weeks postoperative.",[19],"Behavioral: Sleep education therapy (SET)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse",[15],[30],{"name":31,"affiliation":32,"role":33},"Martin F Bjurström, MD, PhD","Uppsala University \u002F Uppsala University Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+46739512728","martin.flores.bjurstrom@uu.se",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Surgical Sciences, Uppsala University","RECRUITING","Uppsala","Uppland","75185","Sweden",{"type":48,"coordinates":49},"Point",[50,51],17.63889,59.85882,{"lat":51,"lon":50},[54,58],{"name":55,"role":36,"phone":56,"phoneExt":25,"email":57},"Andrea Niklasson, M.D.","0046186122110","andrea.niklasson@gmail.com",{"name":59,"role":33,"phone":25,"phoneExt":25,"email":25},"Martin F Bjurström, Associate Professor",{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100527265",false,"NCT06145516","Promoting Sleep to Alleviate Pain - Arthroplasty","Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial","PROSAP-A","Inclusion Criteria:\n\n* age ≥18 years\n* insomnia severity index score \\>10\n* fulfill DSM-V criteria for persistent insomnia disorder\n* average pain numerical rating scale (NRS) score ≥4 (scale 0 - 10) and\u002For movement-related pain NRS score ≥4 after 5 minutes walking\n* scheduled to undergo primary (first-time, i.e., not revision surgery) TKA or THA due to osteoarthritis\n\nExclusion Criteria:\n\n* uncontrolled medical disorders\n* nightshift work\n* ongoing major depressive disorder, bipolar disorder, psychotic disorder, substance dependence\n* current history or high likelihood of primary sleep disorders (other than insomnia), including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus\n* severely impaired vision (precluding ability to take part of study interventions)","ALL","18 Years","100 Years",{"count":73,"type":74},100,"ESTIMATED","INTERVENTIONAL",[77],"NA","PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objective is to evaluate effects of preoperative sleep-promotion on acute postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.",[80,81,82,83,84,85],"Osteoarthritis, Knee","Osteoarthritis, Hip","Insomnia","Surgery","Pain, Postoperative","Postoperative Complications",[87,88,89,90,91,92],"osteoarthritis","total knee arthroplasty","total hip arthroplasty","insomnia","sleep disturbance","postoperative pain","2026-04-29",{"date":95,"type":96},"2026-05-06","ACTUAL",{"date":98,"type":96},"2025-09-01",{"date":100,"type":74},"2030-12-01",{"name":5,"class":6},1]