[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591108":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":48,"centralContacts":58,"locations":68,"responsibleParty":101,"collaborators":103,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":32,"enrollmentInfo":116,"targetDuration":32,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":71,"whyStopped":32,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Behavioral Therapy + Morning Bright Light exposure","EXPERIMENTAL","Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits.\n\nMorning Bright Light involves wearing glasses (Re-Timer Device) that give off a special type of bright light for one full hour in the morning. The participant will be asked to wear these glasses every morning for about four weeks before surgery, four weeks after surgery and again for 1-week , 3-months after surgery. The participant will fill out a log to note light on\u002Foff times, any interruptions to light treatment, and primary activity while receiving the light exposure. The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.",[13,14],"Behavioral: Cognitive-Behavioral Therapy for Insomnia","Device: Bright Light therapy via the Re-Timer®",{"label":16,"type":17,"description":18,"interventionNames":19},"Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure","ACTIVE_COMPARATOR","Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits.\n\nNegative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. the participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.",[13,20],"Device: Negative Ion exposure via IonMi Device",{"label":22,"type":17,"description":23,"interventionNames":24},"Sleep \u002F Knee Osteoarthritis Education + Negative Ion exposure","Sleep \u002F Knee Osteoarthritis Education. This program will focus on increasing the participant's knowledge about sleep, sleep disorders and knee osteoarthritis.\n\nNegative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.",[20,25],"Behavioral: Sleep \u002F Knee Osteoarthritis Education",[27,33,38,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BEHAVIORAL","Cognitive-Behavioral Therapy for Insomnia","This program will focus on changing the participant's sleep patterns, activities, and habits.",[9,16],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"DEVICE","Bright Light therapy via the Re-Timer®","Subjects will conduct light treatment in the mornings at home for one hour using Re-timer® The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery",[9],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Negative Ion exposure via IonMi Device","This procedure involves wearing a light weight negative ionizer (IonMi Device) around neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery",[16,22],{"type":28,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Sleep \u002F Knee Osteoarthritis Education","This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.",[22],[47],"koa Education",[49,52,55],{"name":50,"affiliation":5,"role":51},"Michael T Smith, PhD","PRINCIPAL_INVESTIGATOR",{"name":53,"affiliation":54,"role":51},"Helen Burgess, PhD","University of Michigan",{"name":56,"affiliation":57,"role":51},"Robert R Edwards, PhD","Brigham and Women's Hospital",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":32,"email":63},"Anna Kim-Dahl","CONTACT","410-550-5704","akimdah1@jhu.edu",{"name":65,"role":61,"phone":66,"phoneExt":32,"email":67},"Marise Owens","617-732-9463","mcornelius@bwh.harvard.edu",[69,90],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Johns Hopkins School of Medicine","RECRUITING","Baltimore","Maryland","21224","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-76.61219,39.29038,{"lat":81,"lon":80},[84,85,89],{"name":60,"role":61,"phone":62,"phoneExt":32,"email":63},{"name":86,"role":61,"phone":87,"phoneExt":32,"email":88},"Heavon Allen","4105501000","hallen16@jhmi.edu",{"name":50,"role":51,"phone":32,"phoneExt":32,"email":32},{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":75,"countryCode":76,"cosmosGeoPoint":96,"geoPoint":100,"contacts":32},"Mass General Brigham","ACTIVE_NOT_RECRUITING","Chestnut Hill","Massachusetts","02467",{"type":78,"coordinates":97},[98,99],-71.16616,42.33065,{"lat":99,"lon":98},{"type":102,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[104],{"name":105,"class":106},"National Institute on Aging (NIA)","NIH","100591108","sleep-to-prevent-post-surgical-pain-100591108",false,"NCT06976138","Sleep TO Prevent Post-surgical Pain","STOPPP","Inclusion Criteria:\n\n* People with knee osteoarthritis,\n* 60 years old and older,\n* scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and\n* have trouble falling or staying asleep\n\nExclusion Criteria:\n\n* currently using medications to help sleep\n* have completed Cognitive Behavioral Therapy for Insomnia\n* used either Bright Light or Negative Ion exposures in the past year\n* have an inflammatory rheumatologic disorder, seizure disorder\n* serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder\n* serious sleep or circadian rhythm disorder, untreated sleep apnea\n* are pregnant or lactating\n* have retinal pathology\n* history of eye surgery (Lasik or cataract okay if more than 3 months ago)\n* are taking disease-modifying antirheumatic drugs\n* taking photosensitizing medications\n* are unwilling to discontinue over the counter sleep aids (for example, melatonin) for at least 2 weeks before enrolling","ALL","60 Years",{"count":117,"type":118},252,"ESTIMATED","INTERVENTIONAL",[121],"NA","This research study is being done to compare different methods of addressing sleep problems before total knee replacement surgery. These methods include Cognitive Behavioral Therapy and light exposure.",[124],"Knee Osteoarthristis",[126,127,128,129],"total knee arthroplasty","knee replacement","koa","knee osteoarthritis","2026-08-06",{"date":132,"type":133},"2026-08-07","ACTUAL",{"date":135,"type":133},"2025-06-13",{"date":137,"type":118},"2029-07-31",{"name":5,"class":6},2]