[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100348911":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":63,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":36,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":36,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":36,"overallStatus":66,"whyStopped":36,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Exposed to Day light","EXPERIMENTAL","Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive an intense (bright light, Square One Wake Up Light NatureBright 10,000 LUX) box. The patient will start using the light box prior to surgery every morning from 8.30 to 9.00 AM. Blood \u002Fbuccal swabs will be collected on the day of enrollment (10 to 1 days prior to surgery) between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of light therapy.",[13],"Device: Day Light",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Comparator: Exposed to Room light","PLACEBO_COMPARATOR","Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive a placebo\u002Fcontrol device (dim\u002Fnight light box). The patient will start using the light box 7 days prior to surgery every morning from 8.30 to 9.00 AM. Blood \u002Fbuccal swabs will be collected on the day of enrollment (10 to 1 days prior to surgery) between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of placebo therapy.",[19],"Device: Placebo light",{"label":21,"type":10,"description":22,"interventionNames":23},"Experimental: ICU Exposed to Day light","Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes intense light each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period. This will be facilities by a study nurse.",[24],"Device: ICU Intense Light",{"label":26,"type":16,"description":27,"interventionNames":28},"Sham Comparator: ICU Exposed to Room light","Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes using a placebo\u002Fcontrol device (dim\u002Fnight light box) each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device.",[29],"Device: ICU Placebo light",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Day Light","Patients are exposed to daylight for up to 10 days prior to surgery",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Placebo light","Patients are exposed to placebo light for up to 10 days prior to surgery",[15],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"ICU Intense Light","ICU Patients are exposed to daylight for up to 10 days after surgery",[21],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"ICU Placebo light","ICU Patients are exposed to placebo light for up to 10 days after surgery",[26],[50],{"name":51,"affiliation":52,"role":53},"Tobias Eckle, MD, PhD","UC Denver","PRINCIPAL_INVESTIGATOR",[55,59],{"name":51,"role":56,"phone":57,"phoneExt":36,"email":58},"CONTACT","7209495646","tobias.eckle@cuanschutz.edu",{"name":60,"role":56,"phone":61,"phoneExt":36,"email":62},"Nick Naughton, BS","303-724-0833","NICK.NAUGHTON@CUANSCHUTZ.EDU",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"University of Colorado Denver | Anschutz Medical Campus","RECRUITING","Denver","Colorado","80220-3706","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-104.9847,39.73915,{"lat":76,"lon":75},[79],{"name":80,"role":56,"phone":61,"phoneExt":36,"email":62},"Nick M Naughton, BS",{"type":82,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[84],{"name":85,"class":86},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100348911","bright-light-exposure-in-surgical-patients-100348911",false,"NCT03822949","Bright Light Exposure in Surgical Patients","Bright Light Exposure in Patients Undergoing Non-cardiac Elective Surgery","Inclusion Criteria:\n\n* Patients undergoing primary sternotomy cardiac surgery\n* Subjects in the range of 18 - 90 years old .\n* Patient need to be in sinus rhythm at the time of surgery.\n\nExclusion Criteria:\n\n* patients \\\u003C18 or \\>90 years old\n* participation in other clinical trials within the previous 30 days\n* pregnancy\n* neurological conditions that could impair weaning from ventilator support\n* significant CNS disorders or comorbid irreversible conditions with a six-month mortality rate more than 50 percent\n* prisoners, or subjects with altered capabilities to make decision will be enrolled\n* medical history of type 2 diabetes\n* patients with atrial fibrillation or use of class III anti-arhythmic drug\n* patients with a left ventricle ejection fraction \\\u003C 40%\n* patient in emergency condition","ALL","18 Years","90 Years",{"count":98,"type":99},70,"ESTIMATED","INTERVENTIONAL",[102],"NA","1. Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery. In addition, we hypothesize that light therapy leads to Per2 dependent metabolic optimization in the human cardiac tissue. Therefore, a small piece of human heart tissue from the right atrium will be collected during cardiac cannulation, which will be otherwise discarded.\n2. Critical illness (being in the intensive care unit) results in circadian malfunction and vessels not working. Vessel function is controlled by the body's circadian clock. Intense light boosts the circadian clock and the vessel function in animal studies. Vessels not working well in critical ill patients results in a myriad of severe diseases (delirium, stroke, heart attack, organ damage etc). Thus we will test if intense light can be used to boost the circadian clock and the associated vessel function in critical ill patients.",[105,106,107],"Myocardial Ischemia","Critical Illness","Endothelial Dysfunction","2025-05-09",{"date":110,"type":111},"2025-05-14","ACTUAL",{"date":113,"type":111},"2019-07-12",{"date":115,"type":99},"2026-07-01",{"name":5,"class":6},1]