[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527265":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":88,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of Surgical Sciences, Uppsala University","RECRUITING","Uppsala","Uppland","75185","Sweden","SE",{"type":49,"coordinates":50},"Point",[51,52],17.63889,59.85882,{"lat":52,"lon":51},[55,59],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":58},"Andrea Niklasson, M.D.","0046186122110","andrea.niklasson@gmail.com",{"name":60,"role":33,"phone":25,"phoneExt":25,"email":25},"Martin F Bjurström, Associate Professor",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100527265","promoting-sleep-to-alleviate-pain---arthroplasty-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":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82,83,84,85,86,87],"Osteoarthritis, Knee","Osteoarthritis, Hip","Insomnia","Surgery","Pain, Postoperative","Postoperative Complications",[89,90,91,92,93,94],"osteoarthritis","total knee arthroplasty","total hip arthroplasty","insomnia","sleep disturbance","postoperative pain","2026-04-29",{"date":97,"type":98},"2026-05-06","ACTUAL",{"date":100,"type":98},"2025-09-01",{"date":102,"type":76},"2030-12-01",{"name":5,"class":6},1]