[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yan Fuxia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,63,84,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100640099","metabolomics-and-biomarker-research-on-the-mechanism-of-preoperative-sleep-disorders-affecting-postoperative-outcomes-in-cardiac-surgery-patients-100640099",false,"NCT07588178","Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Cardiac Surgery Patients","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Scheduled for elective cardiac surgery\n\nExclusion Criteria:\n\n1. Has a history of neurosurgery, or has suffered from neurological diseases such as cerebral hemorrhage, cerebral infarction, delirium, dementia, etc.\n2. Has a history of mental disorders.\n3. Heavy alcohol consumption.\n4. American Society of Anesthesiologists (ASA) classification level IV or above.\n5. Complicated with severe liver dysfunction (Child-Pugh C grade) or renal dysfunction (chronic kidney disease stage 3-4).\n6. Unable to communicate due to hearing or language problems, or refuses to sign the informed consent form.","ALL","18 Years","80 Years",{"count":19,"type":20},144,"ESTIMATED","OBSERVATIONAL","This study is titled \"Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Adult Cardiac Surgery\". It aims to clarify the perioperative metabolic changes caused by preoperative sleep disorders in adult cardiac surgery patients, providing ideas for exploring the mechanism by which sleep disorders affect adverse outcomes after cardiac surgery. The study will be conducted at Fuwai Hospital, Chinese Academy of Medical Sciences. By collecting perioperative blood and fecal samples from adult cardiac surgery patients with and without preoperative sleep disorders, and simultaneously recording postoperative clinical outcome indicators (such as the incidence of delirium within 7 days after surgery, cognitive function scores, mechanical ventilation time, ICU stay time, hospital stay time, and severe cardiovascular adverse events), the study will explore the impact of preoperative sleep disorders on perioperative plasma metabolic substances, inflammatory levels, nerve damage, oxidative stress levels, and intestinal flora in adult cardiac surgery patients under general anesthesia, providing ideas and evidence for exploring the mechanism by which preoperative sleep disorders affect postoperative outcomes in adult cardiac surgery patients under general anesthesia.",[24,25],"Delirium - Postoperative","Sleep Problems","RECRUITING","2026-05-08",{"date":29,"type":30},"2026-05-14","ACTUAL",{"date":32,"type":30},"2026-01-01",{"date":34,"type":20},"2026-12-31",{"name":36,"class":37},"Yan Fuxia","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":38},"100583677","preoperative-sleep-intervention-on-postoperative-delirium-in-school-aged-children-undergoing-congenital-heart-surgery-100583677","NCT06879431","Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery","The Impact of Cognitive Behavioral Intervention On Postoperative Delirium In School-aged Children With Sleep Disorder Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 0-36 months\n2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n3. Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \\>48)\n\nExclusion Criteria:\n\n1. Preoperative use of sleep therapy-related medications\n2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4\n3. History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue\n4. Emergency surgery or preoperative ICU admission\n5. History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression\n6. Combined severe hepatic and renal dysfunction\n7. Combination of non-cardiac malformations (adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeoge syndrome, diabetes mellitus, reproductive system abnormalities, anal atresia and Williams syndrome, eye disorders)\n8. History of preoperative cerebral ischemia and hypoxia\n9. Concurrent participation in other clinical trials\n10. Refusal of the family to sign the informed consent form or poor compliance by the child","6 Years","12 Years",{"count":49,"type":20},544,"INTERVENTIONAL",[52],"NA","This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[24,25,55],"Congenital Heart Disease (CHD)","2025-05-27",{"date":58,"type":30},"2025-05-31",{"date":60,"type":30},"2025-04-28",{"date":34,"type":20},{"name":36,"class":37},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":50,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":83,"locationsCount":38},"100582337","preoperative-sleep-intervention-on-postoperative-delirium-in-infants-and-toddlers-undergoing-congenital-heart-surgery-100582337","NCT06861998","Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery","The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 0-3 years\n2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n3. Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).\n\nExclusion Criteria:\n\n1. Infants and toddlers who have taken any relevant preoperative treatment for sleep problems\n2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.\n3. Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.\n4. Presence of any other preoperative acute or chronic medical condition (mechanical ventilation support, history of asphyxia rescue, severe hepatic or renal dysfunction, or comorbidities with other non-cardiac malformations)\n5. Concurrent participation in other clinical trials\n6. Refusal of the family to sign the informed consent or poor compliance of the child.","1 Day","3 Years",{"count":73,"type":20},452,[52],"This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[24,25,55],"2025-05-24",{"date":79,"type":30},"2025-05-28",{"date":81,"type":30},"2025-04-30",{"date":34,"type":20},{"name":36,"class":37},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":50,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":4},"100575827","effect-of-preoperative-sleep-intervention-on-postoperative-delirium-in-adult-patients-undergoing-cardiac-surgery-100575827","NCT06777342","Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery","Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Scheduled for elective coronary artery bypass grafting and\u002For valve surgery.\n3. Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.\n\nExclusion Criteria:\n\n1. History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.\n2. History of mental illness.\n3. Habitual heavy drinking.\n4. American Society of Anesthesiologists (ASA) grade IV or above.\n5. Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).\n6. Contraindications to melatonin use, such as allergies to melatonin-related ingredients.\n7. Currently taking melatonin, melatonin receptor agonists, sleep-related medications, sedatives, antipsychotic medications, or opioids.\n8. Inability to communicate due to hearing or speech impairment, or refusal to provide informed consent.",{"count":92,"type":20},1281,[52],"This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and\u002For valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[24,25,96,97],"CABG","Valve Surgery","NOT_YET_RECRUITING","2025-01-10",{"date":101,"type":30},"2025-01-15",{"date":103,"type":20},"2025-02-01",{"date":34,"type":20},{"name":36,"class":37},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":15,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":117,"studyType":21,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100568847","preoperative-sleep-disorders-and-postoperative-delirium-in-children-undergoing-congenital-heart-surgery-100568847","NCT06686550","Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery","The Impact of Preoperative Sleep Disorders on the Incidence of Postoperative Delirium in Children Undergoing Congenital Heart Surgery: A Prospective, Observational, Cohort Study","Inclusion Criteria:\n\n* Aged more than 28 days and less than 14 years old；\n* Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Combined with severe hepatic and renal dysfunction (with a diagnosis of acute or chronic renal insufficiency or requiring renal replacement therapy; with a diagnosis of acute or chronic hepatic insufficiency or requiring artificial liver treatment);\n* Combined with non-cardiac malformations (adenoidal hypertrophy, tracheobronchial stenosis and ocular disorders);\n* History of preoperative cerebral ischemia or haemorrhage;\n* Refuse to sign the informed consent form or the child has poor compliance.","28 Days","14 Years",{"count":116,"type":20},435,"1 Year","The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.",[24,25,55],"2024-11-11",{"date":122,"type":30},"2024-11-13",{"date":124,"type":20},"2024-11-10",{"date":126,"type":20},"2026-06-15",{"name":36,"class":37},""]